HL7 Medwatch 08192022

eMDR HL7 Pointers - Change Log
Date Worksheet Name Medwatch Form Medwatch Field/Section Name

Changed Reference
11/1/17 3500A_HL7_Pointers E3 - Occupation-text

11/1/17 X_PATH E3 - Other Occupation
11/1/17 xPath to Form E3 - Other Occupation
2/15/18 3500A_HL7_Pointers F10 - Event Problem Codes
2/15/18 3500A_HL7_Pointers H6 - Event Problem and Evaluation Codes
2/15/18 Vocab F10 part 1 - Device Problem code
2/15/18 Vocab F10 part 2 - Patient Problem code
2/15/18 Vocab H6 part 1 - Patient Problem code
2/15/18 Vocab H6 part 2 - Device Problem code
2/15/18 Vocab H6 part 3 - Evaluation code method
2/15/18 Vocab H6 part 4 - Evaluation code results
2/15/18 Vocab H6 part 5 - Evaluation code conclusions
2/22/18 3500A_HL7_Pointers G4 - Date received by manufacturer
2/22/18 3500A_HL7_Pointers G7 - Type of Report
2/22/18 3500A_HL7_Pointers F4 - User Facility Contact Email

2/22/18 Vocab A4 - Weight
2/23/18 3500A_HL7_Pointers E4 - Initial reporter also sent report to FDA
2/26/18 3500A_HL7_Pointers G1 - Manufacturer Contact Facility Name

2/26/18 3500A_HL7_Pointers G3 - Report Source
2/26/18 ChangeLog B5 - Problem Description
2/27/18 3500A_HL7_Pointers D3 - Manufacturer State Code
D9 - Reprocessor State Code
E1 - Initial Reporter State Code
F3 - User Facility State Code
F14 - Manufacturer State Code
G1 - Manufacturer Contact State Code
3/5/18 3500A_HL7_Pointers A4 - Weight

3/5/18 3500A_HL7_Pointers D11 - Concomitant Medical Products
3/27/18 3500A_HL7_Pointers H3 - Device Not Returned to Manufacturer
for Evaluation
3/27/18 Vocab H3 - Device Not Returned to Manufacturer
for Evaluation
1

Changed Reference
3/27/18 Xpath H3 - Device Not Returned to Manufacturer

for Evaluation
3/27/18 xPath to Form H3 - Device Not Returned to Manufacturer
for Evaluation
4/24/18 Vocab C9 - Event Abated After Use Stopped or
Dose Reduced?
4/24/18 Vocab C10 - Event Reappeared After
Reintroduction
4/26/18 3500A_HL7_Pointers F3 - User Facility Contact Email
4/26/18 X_PATH F3 - User Facility Contact Email
4/26/18 xPath to Form F3 - User Facility Contact Email
5/4/18 3500A_HL7_Pointers E3 - Occupation
5/4/18 3500A_HL7_Pointers F9 - Approximate Age of the Device

5/4/18 3500A_HL7_Pointers D4 - Model #, Lot #, Catalog #, Expiration
Date, Serial #, Unique Identifier (UDI)#
5/4/18 Vocab C3 - Routes of Administration
5/4/18 Vocab E3 - Occupation
6/1/18 3500A_HL7_Pointers G7 - Type of Report

6/1/18 Vocab G7 - Type of Report
6/13/18 3500A_HL7_Pointers H2 - If follow-up, what type?
6/13/18 3500A_HL7_Pointers H8 - Usage of device

6/13/18 Vocab F12 - Event Location
6/13/18 X_PATH C9 and C10
6/13/18 xPath to Form C9 and C10

10/31/18 3500A_HL7_Pointers A4 - Weight
12/20/18 3500A_HL7_Pointers D8 - Is this a single-use device that was
reprocessed and reused on a patient?
2

Changed Reference
12/20/18 3500A_HL7_Pointers H3 - Part 4 - Device Not Returned to

Manufacturer for Evaluation?
12/20/18 Sample XML file C9 and C10
3/20/20 Vocab Gender

A3
3/20/20 All Tabs List Medical Product and Treatment Given

C2 at the Same Time of the Event and Date
3/20/20 All Tabs C4 Treatment Dates/Therapy Dates
3/20/20 All Tabs Product Type
C6
3/20/20 All Tabs N/A

C7, C8, C9
3/20/20 3500A_HL7_Pointers Operator of Device
Vocab D5
3/20/20 All Tabs D8 Was this device serviced by a third party?
3/20/20 All Tabs Concomitant Medical Products and Therapy
D10 Dates
3/20/20 All Tabs N/A
D10
3/20/20 Vocab E3 Occupation

3/20/20 3500A_HL7_Pointers F10 Adverse Event Problem
3/20/20 xPath to Form F10 Medical Device Problem Code
3

Changed Reference
3/20/20 xPath to Form Component Code

Vocab F10
3/20/20 xPath to Form F10 Health Effect - Clinical Code
3/20/20 xPath to Form Health Effect - Impact Code
Vocab F10
3/20/20 All Tabs Contact Office (and Manufacturing Site for
G1 Devices) or Compounding Outsourcing
Facility
3/20/20 All Tabs G3, G4, G5, G6, Section G: All manufacturers
G7, G8, G9
3/20/20 All Tabs Premarket Application Numbers and
G4 Premarket Checkboxes
3/20/20 3500A_HL7_Pointers G5 If IND/PreANDA, Give Protocol #
3/20/20 All Tabs H1 Type of reportable event
3/20/20 3500A_HL7_Pointers Type of reportable event
xPath to Form H1 Part 2
3/20/20 3500A_HL7_Pointers H6 Adverse Event Problem
3/20/20 XPATH Sheet N/A N/A
3/20/20 xPath to Form H6 Medical Device Problem Code
3/20/20 xPath to Form H6 Component Code
3/20/20 xPath to Form H6 Health Effect - Clinical Code
3/20/20 xPath to Form H6 Health Effect - Impact Code
3/20/20 xPath to Form H6 Type of Investigation
3/20/20 xPath to Form H6 Investigation Findings
3/20/20 xPath to Form H6 Investigation Conclusions
3/20/20 3500A_HL7_Pointers Corrected Data
Vocab H11
3/20/20 CountryCodeMapping NA NA
3/20/20 All Tabs NA NA
8/2/20 All Tabs C6 Product Type

8/2/20 All Tabs G4 Combination Products
9/14/20 3500A_HL7_Pointers F14 Manufacturer name/address
4

Changed Reference
10/2/20 xPath to Form NA NA

10/2/20 xPath to Form NA
NA
8/19/22 3500A_HL7_Pointers NA Form Code

8/19/22 3500A_HL7_Pointers NA Exemption Number
8/19/22 3500A_HL7_Pointers A2 Age/Age Unit
8/19/22 3500A_HL7_Pointers D2 Type of Device
8/19/22 3500A_HL7_Pointers D2 - Part 1 Common Device Name
8/19/22 3500A_HL7_Pointers D6B If explanted, give date
8/19/22 3500A_HL7_Pointers F3 User Facility Contact Email
8/19/22 3500A_HL7_Pointers F4 User Facility Contact Email
8/19/22 3500A_HL7_Pointers F10 Adverse Event Problem
8/19/22 3500A_HL7_Pointers G1 Manufacturer Contact Email
8/19/22 3500A_HL7_Pointers H6 Adverse Event Problem
8/19/22 CountryCodeMapping NA NA
5
Change Description
Removing from Implementation Package

Update to the code lists url
Update to correct date format in HL7 ICSR Implementation pointers column
Removed ' Follow-up reports on devices should not repeat material that was submitted in the initial report, but should only provide additional or
corrected information on the previously reported event. ' guidance statement
Added User Facility Contact Email field to the implementation package
Added Concept Code for Weight - C25208
Removed ' use null flavor ASKU for unknown.' comment as Null is not allowed
Facility Name updated from VARCHAR2(50) to VARCHAR2(60)

Added field length VARCHAR2(40) for Other Report Source value
Updated Change Log to reflect B5 as a REQUIRED field
Fixed the broken link for states list on usps website
Changed the 'lb' unit value to 'lbs'

Updated the field length to VARCHAR2(50)
Updated the text for field name from 'Device Returned to Manufacturer for Evaluation' to 'Device Not Returned to Manufacturer for Evaluation'
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Change Description
Updated Concept Code, Concept Preferred Term and NCI definition
Updated Concept Code, Concept Preferred Term and NCI definition
Updated the User Facility Contact Email from F4 to F3

Added note to E3: Please do not use any occupation codes that has been retired. Any retired occupation code found in the submission will be
rejected
Updated option list to include week(s)
Added note to reject submission if "Other #" is added to any part of section D4
Inserted new Route of Administration option - "045 - Nasal" and incremented numbers afterwards
Added note to E3: Please do not use any occupation codes that has been retired. Any retired occupation code found in the submission will be
rejected
Updated Text in Column D (HL7 ICSR Implementation pointers) for G7
Updated Thirty-Day columns F (Concept Preferred Term) and G (Definition)
Removing the statement “For all follow-up MDRs, please provide 'NEW' or 'Updated' information ONLY. Do not submit an MDR that includes
old (prior submitted information) and new or updated information”
Removing the statement “Use nullFlavor attribute to indicate unknown.”
Updated NON-HEALTHCARE PROFESSION with C-Code=C134833
Updated list of Event Locations.
Updated X-Path with correct code C9 - C86045
Logging in Change Log that Administrator/Supervisor C Code was updated to C134832 (was C48905) on June 28, 2018.
Changed the 'kgs' unit value to 'kg'
ASKU is not allowed for D8 field in R2. Removed the note to “use ASKU”.
7
Change Description
Added the instruction in pointer sheet for H3 - Part 4 field.

Added Ccode -
Intersex - C45908
Transgender - C154421
Prefer not to disclose - C132222
Renamed Section Header. Old label: "Concomintant Medical Products and Therapy Dates"
Renamed Section Header. Old label: "Therapy Dates"

Renamed Section Header. Old label: "Is the Product Compounded"
Updated list of Product type and its respective Ccodes
OTC - C54068
Compounded - C94031
Generic - C151960
Biosimilar - C156644
PreANDA - C73584
Pre1938 - C93630
Combination Product - C54696
Renumbered MW Form Reference. Old Numbering: C8, C9, C10 respectively; These fields have had their number reduced by one because C7
was rolled into C6
Renamed option "Lay User/Patient" to "Patient/Consumer"
Added code C85488

MedWatch Form Reference changed from D11 to D10
D6 (Implant Date) and D7 (Explant Date) are now renumbered D6a and D6b. D8 (Reprocessed single-use device?) and D9 (Address of
reprocessor) are now renumbered D7a and D7b. D10 (Device Available for Evaluation) and D11 (Concomitant Products and Therapy Dates)
have been reduced by 1 to D9 and D10 because of the reduction in the number of section D fields
Added code "Third Party Servicer"
Renamed Headings
Same xpath. Renamed Section Name "Device Problem Code"
8
Change Description
Introduced new xpath and CCode ( C54577 )
Same xpath. Renamed Section Name "Patient Problem Code"

Phone number (G2) is now part of field G1

Renamed Section Header. Old label: "Contact Office (and Manufacturing Site for Devices)"
Removal of G2 phone number means that all of these fields have their numbers reduced by one
Added xpath for "Device BLA" and "Combination Product"
Renamed Section Header. Old label: "If IND, Give Protocol #" (G6)
Added Summary Report Option; Added Ccode to Summary report - C84831
Added No. of events (NOE) summarized Field
Renamed Headings
Removed "XPATH" excel sheet. Use xpaths defined in 'xPath to Form'. Some xpaths may differ from the earlier version of this document.
Renamed Section Name "Device Problem Code". Note: The xpath has been updated
Renamed Section Name "Patient Problem Code". Note: The xpath has been updated
Same xpath. Renamed Section Name "Evaluation code method"
Same xpath. Renamed Section Name "Evaluation code results"
Same xpath. Renamed Section Name "Evaluation code conclusions"
Added new MW Section.
Replaced ISO Country Codes to FIPS/NIST and GenC Country Codes

Added Exemption Number Field
Removed Combination Product - C54696

Introduced new xpath and refined instruction. Continuing to use CCode ( C54696 )
Modified Section reference from D9 to D7B
9
Change Description
Renamed label from "Attachments" to "Attachment Filename" (Refer Cell C8)

Added xPATH for the Attachment (Cell C9). This is not a new field. This entry was added to represent the instruction in the ICSRImplGuide
Document concerning attachments
Added Field Length

Added Field Length and modified verbiage on format
NEW Validation: Age value, if sent, must be accompanied with an Unit. Do not send one without the other.
Modified verbiage
Common Device Name is no longer required
NEW Validation: Explanted Date must be equal to or greater than Implanted Date
Moved this item from F3 to F4 in this file. No XML change
NEW Validation: Email Address is required
NEW Validation: At least one HECC and one DPC is required
NEW Validation: Email Address is required
NEW Validation: At least one HECC and one DPC is required
Removed duplicate row for MACEDONIA
10
11
12
eMDR HL7 Implementation Pointers
FDA\CDRH\OSB 03/23/2023
Med Watch Form MedWatch Field/Section Name MedWatch 3500A (paper) Instructions HL7 ICSR Implementation pointers
(https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM295636.pdf)
NOTE: Please use one of the following three values for all instances with a nullFlavor attribute: ASKU, NI, or NA
VALIDATION -- the following are validated on your submission: CFN/FEI/HCFA number, field lengths, required fields, FDA/NCI Codes and additional fields marked on this spreadsheet, F10 and H6 codes
Warning: When testing, you must enter
Initial a valid
reports CFN
-- we or FEI encourage
strongly number or your report
you to will values
use null be rejected. Please
defined abovedoinstead
not send a report
of blank number starting with "5555555-".
fields
Supplemental/Follow-up Reports - required fields are -- report number and G7 -- check follow-up and provide a follow-up number; provide discrete data in appropriate field vs. H10. Refer to ICSR Implementation Guide for more details. Note: Supplemental reports are
obtain repeated information from the initial report.
If you submit an initial report and realize that you want to remove the data from the report, you will NOT be able to by submitting a supplemental report and adding a ‘blank’ or ‘null” value to the field. The system will interpret the field as no change from the initial rep
database will not be updated for that field.
Report Number For Manufacturer report number, please use the following format -- 10 digitFEI-4
digit year-5 digit sequence number E.g. 1234567890-2006-00001; 7 digit CFN-4
digit year-5 digit sequence number E.g.- 5555555-2006-00001. At the start of
every new year the 5 digit report sequence number must be reset to 00001 for
the first new initial MDR.
Warning: When testing, you must enter a valid CFN or FEI number or your
report will be rejected. Please do not send a report number starting with
"5555555-".
For User Facility, same format but replace FEI/CFN with HCFA number and pad
with enough zeros in the beginning to make the first part a 10 digit number;
CFN, FEI and HCFA numbers are validated; during testing, please use a
leading 7 with sequence numbers -- example -- CFN-YEAR-70001 or
FEI/HCFA-YEAR-70001; REQUIRED FIELD
Not on Form Form Code Form Code is a field used to identify reports based upon a pre-defined category of reporter. Form code is assigned Enter entire code (including letters and numbers) if instructed by FDA.
and used for analysis of reported events. This is only used when specifically assigned by FDA. Typical format is
F12345.
Not on Form Exemption Number Exemption Number is an administrative identifier used for tracking purposes of approved exemptions, variances, or Enter exemption number if this report has an approved, applicable exemption
alternative forms of adverse event reporting. Exemption Numbers are also referenced in
correspondences/communications between FDA and the recipient of the exemption approval. Typical format is
E1234567.
A Patient Information
A1 Patient Identifier Provide the patient's initials or some other type of identifier that will allow both the submitter and the initial reporter
(if different) to locate the case if contacted for follow-up. Do not use the patient's name or social security number.
The patient's identity is held in strict confidence by FDA and protected to the fullest extent of the law.
A2 Date of Birth Provide the most precise information available. Enter the patient's birthdate, if known, or the patient's age at the DOB is preferred. Use YYYYMMDD format; use full date format; if month or day
time of event onset. is unknown, then use 01 for either
A2 Age If the patient is 3 years or older, use years (e.g., 4 YR) See MedWatch instructions.
If the patient is less than 3 years old, use months (e.g., 24 MO) Indicate time units used as DA - day; MO - Month; YR - Year; WK - Week.
If the patient is less than 1 month old, use weeks (e.g., 2 WK) Stored unit of measure is Days.
A2 Age Unit If the patient is less than 1 week old, use days (e.g., 5 DA) Note: Age Unit is REQURIED if Age is provided and vice versa. Do not send
Provide the best estimate if exact age is unknown one without the other.
A3 Gender Enter the patient's gender. If the adverse event is a congenital anomaly, report the sex of the child Please look at the vocabulary attachment. Use a code to indicate the
appropriate gender
A4 Weight Indicate whether the weight is in pounds (lbs) or kilogram (kg). Make a best estimate if exact weight is unknown. Indicate weight units used as lbs - pounds; kg - kilogram.
A5 Ethnicity Indicate the ethnicity of the patient. Choose only one response. Please do NOT make a best guess. Please look at the vocabulary attachment. Use a code to indicate the
appropriate ethnicity Indicate the ethnicity of the patient. Choose only one
response. Please do NOT make a best guess.
A6 Race Indicate the race of the patient as reported by the patient. You may choose multiple answers for race. Please do Please look at the vocabulary attachment. Use a code to indicate the
NOT make a best guess. appropriate race. Indicate the race of the patient as reported by the patient.
You may choose multiple answers for race. Please do NOT make a best guess.
B Adverse Event or Product Problem

B1 Report Type Choose the appropriate box. Both boxes should be checked if a product problem may have caused or contributed to Please look at the vocabulary attachment. Use a code to indicate adverse
the adverse event. event or product problem
Adverse event: Any incident where the use of a medication (drug or biologic, including human cell, tissue, or cellular
or tissue-based product (HCT/P), at any dose, or a medical device (including in vitro diagnostics) is suspected to
have resulted in an adverse outcome in a patient.
Product problem (e.g., defects/malfunctions): Any report regarding the quality, performance, or safety of any
medical product. This category is selected when reporting device malfunctions that could lead to a death or serious
injury if the malfunction were to recur.
13
B2 Outcomes attributed to adverse event Indicate ALL that apply to the reported event: Please look at the vocabulary attachment. Use a code(s) to indicate an
Death: Check if death was an outcome of the adverse event, or if the cause of the death is unknown. Include the outcome(s).
date of death, if known.
DO NOT check if: The patient died while using a medical product, but there was no suspected association between
the death and the use of the product
A fetus is aborted because of a congenital anomaly, or is miscarried
Life-threatening: Check if suspected that:
The patient was at substantial risk of dying at the time of the adverse event, or
Use or continued use of the device might have resulted in the death of the patient
Hospitalization (initial or prolonged): Check if admission to the hospital or prolongation of hospitalization was a
result of the adverse event.
DO NOT check if:
A patient in the hospital received a medical product and subsequently developed an otherwise non-serious adverse
event, UNLESS the adverse event prolonged the hospital stay
DO check if:
A patient is admitted to the hospital for one or more days, even if released on the same day
An emergency room visit results in admission to the hospital
Note: Emergency room visits that do not result in admission to the hospital should be evaluated for one of the other
serious outcomes (e.g., life-threatening; required intervention to prevent permanent impairment or damage; other
serious (medically important event)
Disability or Permanent Damage: Check if the adverse event resulted in a substantial disruption of a person's ability
to conduct normal life functions.
Congenital Anomaly/Birth Defect: Check if suspected that exposure to a medical product prior to conception or
during pregnancy may have resulted in an adverse outcome in the child.
Required Intervention to Prevent Permanent Impairment/Damage (Devices): if either situation may be due to the
use of a medical device and medical or surgical intervention was necessary to:
Preclude permanent impairment of a body function, or
Prevent permanent damage to a body structure.
Other Serious (Important Medical Events):
Check when, based on appropriate medical judgment, the event may jeopardize the patient and may require
medical or surgical intervention to prevent one of the other outcomes. Examples include allergic bronchospasm
requiring emergency treatment, blood dyscrasias or convulsions that do not result in hospitalization, or the
development of drug dependency or drug abuse. For human cells, tissues, and cellular and tissue-based products
(HCT/P’s), such interventions could include antibiotics in response to a positive culture or clinical suspicion of an
infection, but not as prophylaxis for infection.
Devices: Check ONLY if the other categories are not applicable to the event. Describe the patient outcome in the
actual narrative of the event in block B5.
B2 Date of death Populate Date of Death in 'deceaseTime Value'; use YYYYMMDD format
B3 Date of Event Provide the actual or best estimate of the date of first onset of the adverse event. If day is unknown, month and year Use YYYYMMDD format
are acceptable. If day and month are unknown, year is acceptable.
When a newborn baby is found to have a congenital anomaly, the event onset date is the date of birth of the child
When a fetus is aborted because of a congenital anomaly, or is miscarried, the event onset date is the date
pregnancy is terminated.
If information is available as to time during pregnancy when exposure occurred, indicate that information in narrative
block B5.
B4 Date of this Report Drugs and Biologics, including Human Cells, Tissues, and Cellular and Tissue-Based Products: The date the report Populate with the 'Date report filled out' by manufacturer. CDRH will be
is filled out. changing med watch instructions to coincide with Drugs and Biologics for
electronic reporting; Use YYYYMMDD format
Devices: The date the initial reporter provided the information about the event [i.e., the first person or entity who
initially provided the information to the user facility, manufacturer, or Distributor (Importer)].
B4 Date of this Report

B5 Describe event or problem For an adverse event: Describe the event in detail using the reporter's own words, including a description of what REQUIRED FIELD
happened and a summary of all relevant clinical information (medical status prior to the event; signs and/or
symptoms; differential diagnosis for the event in question; clinical course; treatment; outcome, etc.). If available and
if relevant, include synopses of any office visit notes or the hospital discharge summary. To save time and space
(and if permitted by the institution), attach copies of these records with any confidential information deleted. DO
NOT identify any patient, physician, or institution by name. The initial reporter's identity should be provided in full in
section E. Information as to any environmental conditions that may have influenced the event should be included,
particularly when (but not exclusive to) reporting about a device.
14
B6 Relevant tests/laboratory data Provide all appropriate information, including relevant negative test and laboratory findings, in order to most Please look at the vocabulary attachment. Use the 'text' area to describe
completely convey how the medical work-up/assessment led to strong consideration of medical-product-induced relevant tests/laboratory data
disease as etiology for clinical status, as other differential diagnostic considerations were being eliminated.
Include: Any relevant baseline laboratory data prior to the administration or use of the medical product
All laboratory data used in diagnosing the event; Any available laboratory data/engineering analyses (for devices)
that provide further information on the course of the event
If available, include:
Any pre- and post-event medication levels and dates (if applicable)
Synopses of any relevant autopsy, pathology, engineering, or lab reports
If preferred, copies of any reports may be submitted as attachments, with all confidential information deleted. DO
NOT identify any patient, physician or institution by name. The initial's reporter's identity should be provided in full in
section E.
B7 Other relevant history, including preexisting If available, provide information on: Please look at the vocabulary attachment. Use 'text' for narrative description
medical conditions
Other known conditions in the patient, e.g.,
Hypertension
Diabetes mellitus
Renal/hepatic dysfunction, etc.
Significant history
Race
Allergies
Pregnancy history
Smoking and alcohol use
Drug abuse, etc.
C Suspect Product(s)
C1 Drug Sequence Number Only applies to electronic submissions: Only applies to electronic submissions: If entering a suspect product, then a
For Initial Reports: Drug Sequence Number is a REQUIRED FIELD.
* Assign each suspect drug with a different drug sequence number (1-20).
* No duplicate sequence numbers in the submission.
* Be sure not to have any gaps with your sequence numbers in the submission
* Example: 3 suspect products added. Drug sequence numbers should be 1, 2, and 3. It cannot be 1, 2, and 4.
For Supplemental Report:

* Gaps in the drug sequence number are allowed.
* No gaps in the drug sequence number with respect to all submissions (initial and supplements).
* Example: 2 suspect products added to the initial submission with drug sequence numbers 1 and 2. A
supplemental report containing a new suspect product with a drug sequence number 4.
If you fail to comply with these requirements, your submission will fail during processing.
Drug Type Only applies to electronic submissions: Enter the drug type: NDA, ANDA, BLA, or IND
Approval Number Only applies to electronic submissions: Provide the approval number for the selected drug type
If IND/PreANDA, Give Protocol # Only applies to electronic submissions: If drug type is IND or PreANDA, provide the Protocol #.
Name and Strength Use the trade name as marketed (e.g., if there is a Structured Product Labeling (SPL) for the product, then use the
Product name and/or Active ingredient as it appears in SPL; If there is no SPL and a label is attached to the report,
then use the same naming convention as in the attached label). If unknown or if no trade name, use the generic
Manufacturer/Compounder name (with the manufacturer or labeler’s name, if known). For foreign reports, use both the foreign trade name and
the U.S. generic name.
For human cells, tissues, and cellular and tissue-based products (HCT/Ps), please provide the common name of the
HCT/P and the name of the manufacturer. You can also indicate if the HCT/P has a proprietary or trade name, in
addition to the common name of the HCT/P (e.g., Brand A bone chips, or Brand B skin tissue). Examples: Achilles
tendon, Iliac crest bone, Islet Cells, or human skin.
NDC # or Unique ID The National Drug Code (NDC #) is a universal product identifier for human drugs. NDC is a three-segment number;
zeros and dashes should be included as they appear on the original manufacturer’s product label and/ or
packaging. NDC numbers are particularly useful to the FDA in investigating drug product quality problems.
Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) must have a Unique ID number to track
the product. For reports involving HCT/Ps, this unique ID should be provided in this box.
Lot # If known, include the lot number(s) with all product problem reports, or any adverse event report with a biologic or
medication.
C2 List Medical Product and Treatment Given at the Enter all Suspect Medical Products and Therapy Dates in Section D10
Same Time of the Event and Date
C3 Dose Describe how the product was used by the patient (e.g., 500 mg QID orally or 10 mg every other day IV). For
reports involving overdoses, the amount of product used in the overdose should be listed, NOT the prescribed
amount. Maximum whole number length = 7. Maximum Decimal length = 3.
15
Refer to the General Instructions for Form FDA 3500A MedWatch-APPENDIX for list of Routes of Administration
C3 Describe how the product was used by the patient (e.g., 500 mg QID orally or 10 mg every other day IV). For
reports involving overdoses, the amount of product used in the overdose should be listed, NOT the prescribed
Dose Unit Please look at the vocabulary attachment for ICSH-M2 code list
amount. Maximum whole number length = 7. Maximum Decimal length = 3.
Number of separate dosages
Refer to the General Instructions for Form FDA 3500A MedWatch-APPENDIX for list of Routes of Administration
Frequency
Frequency Unit Please look at the vocabulary attachment for ICSH-M2 code list
Route Used Please look at the vocabulary attachment for ICSH-M2 code list
C4 Treatment Dates/Therapy Dates - Start Date Provide the date administration was started (or best estimate) and the date stopped (or best estimate). If no dates
are known, an estimated duration is acceptable (e.g., 2 years) or, if therapy was less than one day, then duration is
appropriate (e.g., 1 dose or 1 hour for an IV).
For human cells, tissues, and cellular and tissue-based products HCT/Ps, provide the date of transplant and if
Treatment Dates/Therapy Dates - Stop Date applicable, the date of explanation.
NOTE: Use block C4 to record the date that a diagnostic test was performed for reports that involve an in vitro
diagnostic product or radiation therapy.
C5 Diagnosis Use For Provide the indication for which the product was prescribed or used in this particular patient.
C6 Product Type If the product was compounded, select the checkbox. Please look at the attached vocabulary. Populate TRUE if answer is YES;
If the product is sold over the counter, select the checkbox populate FALSE if answer is NO.
If the product is Generic, select the checkbox
If the product is Biosimilar, select the checkbox Multiple selection / codes can be provided.
If the product is PreANDA, select the checkbox
If the product is PRE1938, select the checkbox
C7 Expiration date Include ONLY with all product problem reports and events involving human cells, tissues, and tissue and cellular- Use YYYYMMDD format
based products (HCT/Ps).
C8 Event Abated After Use Stopped or Dose In addition to checking the appropriate box, provide supporting lab tests and dates, if available Please look the vocabulary attachment. Choose a code; populate TRUE if
Reduced? answer is YES; populate FALSE if answer is NO under 'value'
C9 Event Reappeared After Reintroduction In addition to checking the appropriate box, provide supporting lab tests and dates, if available Please look the vocabulary attachment. Choose a code; populate TRUE if
answer is YES; populate FALSE if answer is NO under 'value'
D Suspect Medical Device
D1 Brand Name The trade or proprietary name of the suspect medical device as used in product labeling or in the catalog (e.g., Flo-
Easy Catheter, Reliable Heart Pacemaker, etc.). This information may 1) be on a label attached to a durable device,
2) be on a package of a disposable device, or 3) appear in labeling materials of an implantable device.
Single use reprocessed devices may bear the OEM's brand name. If the suspect device is a reprocessed single-use
device, enter "NA".
D2 Type of Device Provide Product Code and Common Device Name

D2 - Part 1 Common Device Name Use the generic or common name of the suspect medical device or a generally descriptive name (e.g., urological Provide Common Device Name under 'text';
catheter, heart pacemaker, patient restraint, etc.). Do not use broad generic terms such as "catheter", "valve",
"screw", etc…
D2 - Part 2 Procode Use the Product Code assigned to the device based upon the medical device product classification designated Provide Product Code which was assigned at the time the device was approved
under 21 CFR Parts 862-892. Product codes may be found at under a PMA or cleared under a 510(k). (it lies within the "code" element in the
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/PCDSimpleSearch.cfm XML instance); Note that Concept Code is not used for product code in the xml
file, populate actual product code in the 'code' element. Please refer to VOCAB
sheet for FDA OID; REQUIRED FIELD
D3 Manufacturer name & address If available, enter the full name and mailing address of the manufacturer of the suspect medical device. If Block D7A For HL7 Name and Address, please provide the following, as applicable --
below is 'Yes', enter the name and address of the reprocessor. Manufacturer Name, Street Address Line 1, Street Address Line 2, City, State,
Postal Code, Country;
Manufacturer Name
Manufacturer Address Street Line 1
Manufacturer City Enter US City or Foreign (State/Territory/Province)
Manufacturer State Code Please refer to https://pe.usps.com/text/pub28/28apb.htm for appropriate state
codes for United States
Manufacturer Zip Code The Five digit zip code
Manufacturer Zip Code Extension The 4 digit zip code extension
Manufacturer Country Code Current CDRH Implementation will support both 2 character and 3 character
country codes. Please refer to the countryCodeMapping sheet.
Manufacturer Postal Code Postal Code for international addresses - 10 digit string
Manufacturer Email
Manufacturer Fax Number provide a string with no formatting, can not be longer than 26 chars
16
D4 Model #, Lot #, Catalog #, Expiration Date, Model #, Catalog #, Serial #, Lot #, Expiration date, Unique Identifier (UDI) NOTE: Do not add "Other #" as part of section D4 or in the UDI field. Any
Serial #, Unique Identifier (UDI)# submission that contains "Other #" data will be rejected
If available, provide any expiration date or any or all identification numbers associated with the suspect medical
device exactly as they appear on the device or device labeling. This includes spaces, hyphens, etc.
Model #: The exact model number found on the device label or accompanying packaging
Catalog #: The exact number as it appears in the manufacturer's catalog, device labeling, or accompanying
packaging
Serial #: This number can be found on the device label or accompanying packaging; it is assigned by the
manufacturer and should be specific to each device
Lot #: This number can be found on the label or packaging material
Expiration date: If available; this date can often be found on the device itself or printed on the accompanying
packaging.
Unique Identifier (UDI) #: The Unique identification number for the suspect device - Provide only the DI # portion of
the UDI
D4 Model Number
D4 Lot Number
D4 Catalog Number
D4 Expiration Date Use YYYYMMDD format
D4 Serial Number
D4 Unique Identifier (UDI) # An identifier that adequately identifies a device through its distribution and use by meeting the requirements of 21 NOTE: Do not add "Other #" as part of section D4 or in the UDI field. Any
CFR 830.20 of this chapter. A unique device identifier is composed of a (1) device identifier and (2) production submission that contains "Other #" data will be rejected
identifier.2 21 CFR 801.3. For more information regarding UDI, refer to the following FDA link:
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/
UCM410439.pdf
NOTE: Manufacturer and distributor reports should include the DI only. User Facility reporters who cannot parse
the DI out of the complete UDI should include the whole human-readable UDI.
D5 Operator of device - Code Indicate the type (not the name) of person operating or using the suspect medical device on the patient at the time Please look at the vocabulary attachment.
of the event as follows:
Health professional = physician, nurse, respiratory therapist, etc.

Patient/Consumer = person being treated, parent/spouse/friend of the patient
Other = nurses aide, orderly, etc...
D5 Operator of Device - Other Use the 'text' area to describe 'Other'

D6A If Implanted give date For medical devices that are implanted in the patient, provide the implant date or best estimate. If day is unknown, Use YYYYMMDD format
month and year are acceptable. If month and day are unknown, year is acceptable.
D6B If explanted, give date If an implanted device was removed from the patient, provide the explant date or best estimate. If day is unknown, Use YYYYMMDD format
month and year are acceptable. If month and day are unknown, year is acceptable.
Note: Explanted Date must be greater than or equal to Implanted Date
D7A Is this a single-use device that was reprocessed Indicate "Yes" or "No" Please look at the vocabulary attachment. Choose a code; populate TRUE if
and reused on a patient? If the original equipment manufacturer (OEM) is unable to determine if their single use device was reprocessed and answer is YES; populate FALSE if answer is NO under 'value'.
reused on a patient, then the OEM should enter 'UNK' in Block D8 and in Block H10 (Additional Manufacturer
Narrative) describe the efforts made to obtain the information and any responses.
D7B If yes to item D7A, enter name and address of Enter the name and address of the reprocessor of the single-use device. For Name and Address, please provide the following, as applicable --
reprocessor Reprocessor Name, Street Address Line 1, Street Address Line 2, City, State,
Any entity that reprocesses single-use devices for reuse in humans is the manufacturer of the reprocessed single- Postal Code, Country;
use device.
Reprocessor Name
Reprocessor Address Street Line 1
Reprocessor Address Street Line 2
Reprocessor City Enter US City or Foreign (State/Territory/Province)
Reprocessor State Code Please refer to https://pe.usps.com/text/pub28/28apb.htm for appropriate state
Reprocessor Zip Code The Five digit zip code
Reprocessor Zip Code Extension The four digit Zip code extension
Reprocessor Country Code Current CDRH Implementation will support both 2 character and 3 character
Reprocessor Postal Code Postal Code for international addresses - 10 digit string
Reprocessor Email
Reprocessor Fax Number provide a string with no formatting, can not be longer than 26 chars
D8 Was this Device serviced by a third party? Indicate "Yes" or "No" or Unknown Please look the vocabulary attachment. Choose a code; populate TRUE if
answer is YES; populate FALSE if answer is NO under 'value'
D9 Device available for evaluation? Date returned to Indicate whether the device is available for evaluation by the manufacturer. Indicate if the device was returned to Please look the vocabulary attachment. Choose a code; populate TRUE if
Manufacturer the manufacturer and, if so, the date of the return. answer is YES; populate FALSE if answer is NO under 'value'
Do not send the device to FDA.
17
D9 - Part 2 Date device returned to manufacturer Indicate whether the device is available for evaluation by the manufacturer. Indicate if the device was returned to Populate a date if answer is YES under 'effectiveTime value';
the manufacturer and, if so, the date of the return. Use YYYYMMDD format
D10 Concomitant Medical Products and Therapy List and provide product names and therapy dates for any other medical products (drugs, biologics, including Please look at the vocabulary attachment. ; Use 'text' for narrative; multiple
Dates human cells, tissues, and cellular and tissue-based products (HCT/Ps), or medical devices, etc.) that the patient products can be entered
was using at the time of the event. Do not include products used to treat the event.
NOTE: Enter any Concomitant Medical Products and Therapy Dates from Section C2 in Suspect Products into
Section D10
D10 - Part 2 Concomitant Medical Products and Therapy Therapy Dates Indicate Therapy date if available under 'effectiveTime value';
Dates Use YYYYMMDD format;
E Initial Reporter
E1 Initial Reporter Name Name should be reported as -- First Name, Middle Name, Last Name;
Please provide the name, mailing address, and phone number of the person who initially reported the adverse
event to the user facility, manufacturer, or Distributor (Importer), and who can be contacted to provide information
on the event if follow-up is necessary. If available, provide reporter's E-mail address and/or fax number.
For medical device reporting by user facilities, this person may or may not be the designated medical device
reporting (MDR) contact.
Initial Reporter First Name
Initial Reporter Middle Name
Initial Reporter Last Name
Initial Reporter Title
E1 Address Address as -- Street Address Line 1, Street Address Line 2, City, State, Postal
Code, Country;
Initial Reporter Facility Name
Initial Reporter Street Address Line 1
Initial Reporter Address Street Line 2
Initial Reporter City Enter US City or Foreign (State/Territory/Province)
Initial Reporter State Code Please refer to https://pe.usps.com/text/pub28/28apb.htm for appropriate state
Initial Reporter Zip Code The Five digit zip code
Initial Reporter Zip Code Extension The four digit Zip code extension
Initial Reporter Country Code Current CDRH Implementation will support both 2 character and 3 character
Initial Reporter Postal Code Postal Code for international addresses - 10 digit string
Initial Reporter Email provide email address under 'telecom value' following prefix "mailto:"
Initial Reporter Fax Number provide a string with no formatting, can not be longer than 26 chars
E1 Phone # Please provide phone number in the following format -- “+” country_code “(“
area_code “)” 3-digit prefix “-“ 4-digit number “x“ up to 5-digit extension
e.g. +1(240)276-0001x12345; if extension is not applicable, leave it out;
international numbers would follow the same format -- e.g. “+” phone_country “(“
phone_city “)” phone_local -- +011(123)1234567890 or if there is no phone_city:
+011()1234567890
E2 Health Professional? E2: Health Professional?: Indicate whether the initial reporter is a health professional (e.g., physician, pharmacist, For HL7, value of E2 will be inferred from E3
nurse, etc.) or not. If not a health professional, complete block E3 by filling in NA.
E3 Occupation Indicate the initial reporter's occupation (particularly type of health professional), and include specialty if appropriate. Please look at the vocabulary attachment. Occupation is not a required field.
NOTE: The information you provide for occupation title will not be used in any
downstream systems.
NOTE: Please do not use any occupation codes that has been retired. Any
retired occupation code found in the submission will be rejected
E4 Initial reporter also sent report to FDA Indicate whether the initial reporter also notified or submitted a copy of this report to FDA. Populate 'false' if answer is YES; populate 'true' if answer is NO
F For Use by User Facility/Distributor (Importer) (Devices Only)
F1 Check one: user facility, importer Indicate whether the report is from a user facility or Distributor (Importer). Please look at the vocabulary attachment under Type_of_Reporter. Choose an
appropriate code
F2 UF/Distributor (Importer) Report Number Enter the complete number of the report exactly as entered in the upper right corner of the front page. For a follow-
up report, the UF/Distributor (Importer) report number must be identical to the number assigned to the initial report.
NOTE: Once you have filled out F2 (user facility number), F1 will automatically get populated.
F3 User Facility or Distributor (Importer) Enter the full name and address of the user facility or Distributor (Importer) reporting site. For Name and Address, please provide the following, as applicable -- User
Name/Address Facility Name, Street Address Line 1, Street Address Line 2, City, State, Postal
Code, Country;
F3 User Facility Name
User Facility Address Street Line 1
User Facility Address Street Line 2
User Facility City Enter US City or Foreign (State/Territory/Province)
User Facility State Code Please refer to https://pe.usps.com/text/pub28/28apb.htm for appropriate state
User Facility Zip Code The Five digit zip code
18
User Facility Zip Code Extension The four digit Zip code extension
User Facility Country Code Current CDRH Implementation will support both 2 character and 3 character
User Facility Postal Code Postal Code for international addresses - 10 digit string
F4 Contact person Enter the full name of the medical device reporting (MDR) contact person. This is the person designated by the Name should be reported as -- First Name, Middle Name, Last Name; provide
facility's most responsible person as the device user facility/Distributor (Importer) contact for this requirement. FDA title.
will conduct its MDR correspondence with this individual. The contact person may or may not be an employee of the
facility. However, the facility and its responsible officials will remain the parties ultimately responsible for compliance
with the MDR requirements.
F4 User Facility Contact Last Name

User Facility Contact First Name
User Facility Contact Middle Initial
User Facility Contact Title
User Facility Contact Email REQUIRED FIELD
F5 Phone Number Enter the phone number of the MDR contact person. Please provide phone number in the following format -- “+” country_code “(“
area_code “)” 3-digit prefix “-“ 4-digit number “x“ up to 5-digit extension
International numbers would follow the same format -- e.g. “+” phone_country “(“
+011()1234567890
F6 Date user facility or Distributor (importer) Enter the date that the user facility's medical personnel or the Distributor (Importer) became aware that the device Use YYYYMMDD format
became aware of event has or may have caused or contributed to the reported event.
F7 Type of report Check the appropriate box to identify the type of report being filed, i.e., an initial report of an event or a follow-up to Please look at the vocabulary attachment. Choose an appropriate code;
a previously submitted report.
If a follow-up report, make sure that the UF/ Distributor (Importer) report number for the previously submitted initial
report is recorded in block F2. In the blank provided in block F7, record the appropriate sequence of follow-up to
that particular initial report (e.g., first follow-up report=follow-up #1, second follow-up report=follow-up #2, and so
on).
Follow-up reports should not repeat material that was submitted in the initial report, but should ONLY provide
additional or corrected information on the previously reported event.
F7 Type of Report\Follow-up Number Populate follow-up number under /pertinentInformation1/sequenceNumber

value/
F8 Date of this report Enter the date that the report was forwarded to the manufacturer and/or the FDA. IGNORE: This will be pre-filled from date provided in either F11 or F13
F9 Approximate age of device Enter the age of the device or a best estimate (include unit of time used: e.g., day, week, month, year). Please look at the vocabulary attachment. Choose an appropriate code.
Populate appropriate number or text; Indicate time units used as DA - day; MO
- Month; YR - Year; WK - Week.
F9 Approximate age of device\Text Please look at the vocabulary attachment. Choose an appropriate code. Device
age text
F10 Event problem codes (refer to coding manual) Enter up to 3 "patient" and 3 "device" codes from the Codes Manual that most accurately describe the event. Provide as many adverse event codes as appropriate; no limitation on number
Patient codes describe what happened to the patient as a result of the event and device codes describe device of values; Please visit
failures or problems encountered during the event. If more than 3 "patient" codes or more than 3 "device" codes are https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/
needed, record them on a separate sheet, mark it "F10", and provide the report number and page number. PostmarketRequirements/ReportingAdverseEvents/MDRAdverseEventCodes/
ucm584205.htm for the list of valid values
If a user facility or a Distributor (Importer) has reason to believe that a reused device has or may have caused or
contributed to an adverse event, the device problem code 1537 ("Reuse") should be entered in F10 along with any Note: At least 1 HECC and 1 DPC code is REQUIRED
other applicable device and/or patient-related codes
F10 part 1 Health Effect - Clinical Code
F10 part 2 Medical Device Problem Code
F10 part 3 Component Code
F10 part 4 Health Effect - Impact Code
F11 part 1 Report sent to FDA? Check yes or no and indicate the date sent, if applicable. Please look at the vocabulary attachment. Populate 'false' if answer is YES;
populate 'true' if answer is NO
F11 Part 2 Date Report Sent Check yes or no and indicate the date sent, if applicable. If answer is YES, provide date report sent to FDA under 'time value';
Use YYYYMMDD format
F12 Location where event occurred Check the location of the actual occurrence of the event. If none of the designated location options apply, check the Please look at the vocabulary attachment. Choose an appropriate code.
other box and provide the location.
19
F12 Location where event occurred\text to explain Use 'text' to describe 'Other'
OTHER
F13 Report sent to manufacturer? Check yes or no and indicate the date sent, if applicable. Please look at the vocabulary attachment. Populate 'false' if answer is YES;
populate 'true' if answer is NO; Please look at the vocabulary attachment.
F13 Part 2 Date Sent to Manufacturer If answer is YES, provide date report sent to FDA under 'low value' (Beginning
of the time interval captures when the report was sent to manufacturer. 'high
value' will be populated under G4 to indicate when the report was received by
the manufacturer; Use YYYYMMDD format
F14 Manufacturer name/address Enter full name and address of the device manufacturer, if available. This would normally be identical to the address For Name and Address, please provide the following, as applicable --
in D3. However, if the device was reprocessed, then F14 is identical to D7B, the name and address of the Manufacturer Name, Street Address Line 1, Street Address Line 2, City, State,
reprocessor. Postal Code, Country;
F14 Manufacturer Name
Manufacturer City Enter US City or Foreign (State/Territory/Province)
Manufacturer State Code Please refer to https://pe.usps.com/text/pub28/28apb.htm for appropriate state
Manufacturer Zip Code The Five digit zip code
Manufacturer Zip Code Extension The four digit Zip code extension
Manufacturer Country Code Current CDRH Implementation will support both 2 character and 3 character
Manufacturer Postal Code Postal Code for international addresses - 10 digit string
Manufacturer Email
Manufacturer Fax Number provide a string with no formatting, can not be longer than 26 chars
G All manufacturers
G1 Contact Office (and Manufacturing Site for Enter the full name and address of the manufacturer reporting site [contact office], including contact name. If the Please ALWAYS submit the MDR CONTACT information as the first address in
Devices) manufacturing site of the device is not the same as the contact office, enter site and the name and address of the the HL7 message. Repeat the <contactParty> block second time and provide
or Compounding Outsourcing Facility manufacturing site after the contact office name and address. MANUFACTURING SITE address. Please note that the sequence of the
address is extremely important and you MUST maintain the order of MDR
Contact Info first and Manufacturing Site info second. For Name and Address,
please provide the following, as applicable -- Name -- Title or prefix, First Name,
Middle Name, Last Name; Address -- Manufacturer Facility Name, Street
Address Line 1, Street Address Line 2, City, State, Postal Code, Country;
G1 Manufacturer Contact Title

Manufacturer Contact First Name
Manufacturer Contact Middle Name
Manufacturer Contact Last Name
Manufacturer Contact Facility Name
Manufacturer Contact Address Street Line 1
Manufacturer Contact Address Street Line 2
Manufacturer Contact City Enter US City or Foreign (State/Territory/Province)
Manufacturer Contact State Code Please refer to https://pe.usps.com/text/pub28/28apb.htm for appropriate state
Manufacturer Contact Zip Code The Five digit zip code
Manufacturer Contact Zip Code Extension The four digit Zip code extension
Manufacturer Contact Country Code Current CDRH Implementation will support both 2 character and 3 character
Manufacturer Contact Postal Code Postal Code for international addresses - 10 digit string
Manufacturer Contact Email provide email address under 'telecom value' following prefix "mailto:".
REQUIRED FIELD
Manufacturer Contact Fax Number provide a string with no formatting, can not be longer than 26 chars
G1 Compounding Outsourcing Facility 503B? DO NOT USE.
G1 Outsourcing Facility DO NOT USE.
G1 Phone number Enter the telephone number of the contact office (devices) or a representative knowledgeable about the report Please provide phone number in the following format -- “+” country_code “(“
(drugs; biologics, including HCT/Ps). area_code “)” 3-digit prefix “-“ 4-digit number “x“ up to 5-digit extension
International numbers would follow the same format -- e.g. “+” phone_country “(“
+011()1234567890
20
G2 Report source Check the box(es) that most accurately describe(s) how the manufacturer [contact office] became aware of the Please look at the vocabulary attachment. Choose an appropriate code; use
reported adverse event or from where the information about the adverse event originated. Foreign: Foreign 'text' to explain 'OTHER'
sources include foreign governments, foreign affiliates of the application/license holder, foreign licensors and
licensees, foreign medical facilities, etc. The country of origin should be included.
Study: Post marketing, clinical trial, surveillance, or other study that involves a systematic collection of adverse
events from a protocol designed specifically to investigate product safety.
Literature: If the report source is the scientific literature or an unpublished manuscript, a copy of the article or
manuscript must be attached. Foreign language articles should be translated into English. Record the date of the
article as the date of the event (block B3), and provide a full literature citation in block H10. Drugs and Biologics,
including HCT/Ps : A separate 3500A form must be completed for each identifiable patient described in the article or
manuscript. Consumer (including attorneys): Additional information, whenever possible, should be sought from the
treating healthcare provider. A determined effort should be made to obtain additional detailed information from
health professionals for all serious reactions, adverse events & product problems initially reported by consumers.
When this additional information is obtained, the follow-up report should check health professional rather than
consumer in block G3. Health professional: Physician, pharmacist, nurse, etc.
User facility: User facility should be checked if the manufacturer received the report from the MDR contact in a user
facility as identified in section F. The health professional should be listed as the initial reporter on the front page of
the form. Company representative: This check box would be selected if a company representative reported the
event to the contact office based on information received from a health professional. The health professional should
be listed as the initial reporter in Section E. Distributor: This check box would be selected for a report received from
the distributor (importer) of the suspect product. The health professional or other reporter should be listed as the
initial reporter on the front page of the form. Other: Any source not covered by the previous categories. For drug or
biologic, including HCT/P manufacturers, this check box would be selected when submitting a follow-up to a report
originally obtained from FDA through a MedWatch to Manufacturer program transmission of a serious direct report,
and the FDA-assigned report number entered into the space provided. Other may also be used to identify when the
source is another manufacturer - include the Manufacturer Report Number of the other manufacturer.
G3 Date received by manufacturer This means the date when the applicant, manufacturer, corporate affiliate, etc. receives information that an adverse Populate the date as 'high value' under
event or medical device malfunction has occurred. This would apply to a report received anywhere in the world. /pertinentInformation1/secondaryCaseNotification/receiver
(YYYYMMDD format) negationInd/time/high value; Use YYYYMMDD format
Follow-up reports: Use the date that the follow-up information was received.
G4 Premarket Application Numbers and Premarket This block is for use by all manufacturers of drug, device, biological products [including cell, tissue, and cellular and Provide either the PMA/510(k) number or Device BLA number. DO NOT use
Checkboxes tissue-based products (HCT/P)] and combination products. Provide whatever information is applicable to the this field for Drug BLAs. If there are any suspect products (or Drugs) associated
suspect product identified in section C or suspect medical device identified in Section D. If the report lists two with the adverse event, enter the suspect product information in Section C of
products by the same applicant as suspect, the report should be submitted to the application file of the product the 3500A Form including the product type and approval number for (A)NDA,
thought by the initial reporter to be the more likely cause of the adverse event. If they are equally suspect, the report IND, or BLA.
should be submitted to the application file of the product that is first alphabetically. (A)NDA #: The abbreviated new
drug application or the new drug application (NDA) number. The report should be filed to the first approved NDA if a Product Type checkboxes such as Combination Product, Compounded, OTC,
product has several NDAs and the specific one cannot be determined. PMA/510(k) #: The pre-market application Pre-1938 and PreANDA, should be entered in Section C
(PMA) or pre-market notification [510(k)] submission number for the approved / cleared medical device or
combination product. If a product has several applicable PMA/510(k)’s and the specific one cannot be determined,
then the first approved / cleared PMA or 510(k) number should be reported. Combination Product: Check the box if
the suspect product is comprised of a drug-device, device-biological, drug-biological , or a drug-device-biological
product, Pre-1938: Check the box if the suspect medication was marketed prior to 1938 and does not have an NDA
#.
G4 PMA / 510k Enter CDRH supplied PMA / 510k Application number Enter CDRH apporved application number with prefix
G4 BLA # Enter Device BLA number, if available Enter Device BLA application number along with the prefix eg. BLA.
DO NOT use this field to capture Drug BLA number, for which, use Section C.
G4 Combination Product If the product is a Combination product, select the checkbox Include the C-code listed in the vocabulary attachment, if this is a combination
product device. Note that Suspect Product information is NOT required in
Section C to identify a combination product.
G5 If IND/PreANDA, Give Protocol # This block is for use by drug and biologic, including HCT/P manufacturers only. If the form is being used as a written If available, enter the Protocol # in Section C Suspect Product Information. Be
IND safety report, enter the protocol number. sure to select IND or PreANDA as the Suspect Drug Product Type.
21
G6 Type of report Select ALL the check boxes that apply to reported event. 5-day: As specified in the device regulations, for reports of Please look at the vocabulary attachment. Choose an appropriate code.
adverse events that necessitate remedial action to prevent an unreasonable risk of substantial harm to the public
health, or are required by FDA by written notice.
30-day: This choice was added in the 2006 version of the 3500A. DO NOT USE THIS OPTION for an initial
report - preferred selection is Initial. As specified in device regulations, for initial reports of a device that may
have caused or contributed to a death or serious injury or for a device malfunction that would be likely to contribute
to a death or serious injury if it were to recur. Periodic: As specified in the drug and biologic regulations, for reports
of serious labeled and non-serious (labeled and unlabeled) adverse events.
Initial: Check if the report is the first submission of a manufacturer report. For devices, this is the 30-day report.
USE INITIAL report, NOT 30-day report, to specify an initial report to the FDA CDRH.
Follow-up: Check if the report is a follow-up to a previously submitted report. Follow-up reports on drugs and
biologics, including HCT/Ps, should contain information that was submitted in the original report if the information is
still correct.
If a follow-up report, make sure that the manufacturer report number for the previously submitted initial report is
recorded in block G9. In the blank provided in block G7 after follow-up, record the appropriate sequence of
follow-up to that particular initial report (e.g., first follow-up report=follow-up #1, second follow-up report=follow-up
#2, and so on).
G6 Type of Report\Follow-up Number Preferred Use 'text' to populate 'follow-up' number

G7 Adverse Event Term(s) For use by drug and biologic, including human cell, tissue, and cellular and tissue-based product (HCT/P), Freeform text field. Separate each Term with a semicolon
manufacturers only.
Include a list of adverse event terms that most accurately characterize the adverse event described in narrative
format in block B5. Terms should be listed with the most important term(s) first. The terminology may be an
accepted standard (e.g., MEDDRA or WHOART), a verbatim term, or the manufacturer’s own terminology.
G8 MFR Report # For all manufacturers: Entry of the Manufacturer Number is not necessary for section G9 since it was
Enter the Manufacturer report number exactly as it appears in the “Mfr Report #” field in the upper right corner of the captured initially within the Report Number screen.
first page. For a follow-up report, the Manufacturer report number must be identical to the number assigned to the
initial report
For drug and biologic manufacturers:
The manufacturer report number is the number the manufacturer chooses to uniquely identify the report, and
should conform to any applicable regulations or guidance.
If submitting a follow-up to a report originally obtained from FDA through a MedWatch to Manufacturer program
transmission of a serious direct report, check the other box in block G3 and enter the FDA-assigned report number
there.
For human cell, tissue, and cellular and tissue-based product (HCT/P) manufacturers:
The report number should consist of three numbers separated by dashes. The first number will be the 10-digit FDA
Establishment Identifier (FEI) number, which was assigned to you as part of the Human Cells and Tissue
Establishment Registration (HCTERS). The second number should be the year that you are submitting the report.
The last number should be a consecutive 5-digit number for each report filed during the year by the manufacturer.
Example: 1234567890-2005-00005.
H Device manufacturers only

H1 Part 1 Type of reportable event Check the appropriate box. These choices represent the categories of events that device manufacturers are THIS FIELD IS REQUIRED FOR ELECTRONIC SUBMISSIONS ONLY.
required to report. Please look at the vocabulary attachment.
Death: Check only if the death was an outcome of the adverse event. Please choose one of the following: Death/Serious Injury/Malfunction.
Serious injury: An adverse event that is life-threatening; results in permanent impairment of a body function or Summary report information is contained in H1 Part2.
permanent damage to a body structure; or necessitates medical or surgical intervention to preclude permanent
impairment of a body function or permanent damage to a body structure.
Malfunction: See the guidelines. ("See the guidelines" refers to the applicable sections in 21 CFR Part 803 reporting
guidelines associated with device malfunctions).
Summary Report: Check this option if Number of Events is a positive Integer.
H1 Part 2 No. of events (NOE) summarized A measurement of the total number of events that have occurred. Leave blank for non-summary reports, for summary reports include a positive
integer
22
H2 If follow-up, what type? Check the box(es) that most accurately describes the nature of the follow-up report. Please look at the vocabulary attachment. Choose an appropriate code. If you
want to send attachments, please submit them under
Correction: Changes to previously submitted information. /pertinentInformation3/document.
Additional information: Information concerning the event that was not provided in the initial report because it was not Base64 is an encoding method that converts binary data (zeros and ones) into
known/available when the report was originally submitted. ASCII text and vice versa. It was originally devised to make it possible to
Response to FDA request: Additional information requested by FDA concerning the device/event. reliably transmit data and is one of the methods used by MIME. Base64 divides
Device evaluation: Evaluation/analysis of device. each three bytes of the original data into four 6-bit units, which it represents as
four 7-bit ASCII characters. It is typical to use MIME base64 encoding to
encode email attachments as well as binary data in XML files. To embed a file
type within an XML document, you have to encode it in a fashion that is
compatible with text. Base64 encoding is used to accomplish this.
As an example, the process would roughly be the following to encode a PDF:
1. Run a program/method which would convert the PDF file to base-64:
PDFInBase64 = convertToBase64("c:\myAttachment.pdf")
2. Insert it into a XML instance after converting to string.
<document><text mediaType="text/plain">Base64 representation of
PDF</text></document>
There are several free, base64 encoding utilities and libraries available on the
internet in a variety of languages and platforms.
H3 part 1 Device evaluated by mfr? YES/NO Check the box marked not returned to mfr. if an evaluation could not be made because the device was not returned Please look at the vocabulary attachment. Populate 'true' for YES, Device
to, or made available to, the manufacturer. Check the box marked yes if an evaluation was made of the suspect or Evaluated; 'false' for NO, Device not evaluated
related medical device. If an evaluation was conducted, attach a summary of the evaluation and check the box
marked evaluation summary attached. If an evaluation of a returned suspect or related medical device was not
conducted, check the box marked no and attach a page to explain why not or provide the appropriate code from the
codes manual in the space provided.
H3 part 2 Device evaluated by mfr? Summary Attached Please look at the vocabulary attachment. Populate 'true' for YES, Evaluation
YES/NO Summary Attached; 'false' for NO, Evaluation Summary not attached;
H3 part 3 Device evaluated by mfr? Evaluation Summary Please look at the vocabulary attachment. Please use the appropriate concept
or reason for not evaluating code; use FDA codes to explain reason for non-evaluation as defined in
http://www.fda.gov/cdrh/mdrcode.pdf, for section H3. For other, please provide
explanation under the text field
H3 part 4 Device Not Returned to Manufacturer for Enter false for not returned to manufacturer, or enter true for returned to
Evaluation? manufacturer.
H4 Device manufacture date Enter the month and year of manufacture of the suspect medical device using a MM/YYYY date format. Use YYYYMMDD format
H5 Labeled for single use? Indicate whether the device was labeled for single use or not. If the question is not relevant to the device being Please look at the attached vocabulary. Choose an appropriate code. Populate
reported (e.g., an X-ray machine), check no. 'true' for YES; 'false' for NO;
H6 Adverse Event Problem Codes (refer to coding Enter up to 3 "patient" and 3 "device" codes from the Codes Manual that most accurately describe the event. Provide as many adverse event codes as appropriate; no limitation on number
manual) Patient codes describe what happened to the patient as a result of the event and device codes describe device of values; Please visit
failures or problems encountered during the event. If more than 3 "patient" codes or more than 3 "device" codes are https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/
needed, record them on a separate sheet, mark it "F10", and provide the report number and page number. PostmarketRequirements/ReportingAdverseEvents/MDRAdverseEventCodes/
ucm584205.htm for the list of valid values
If a manufacturer has reason to believe that a reused device has or may have caused or contributed to an adverse
event, the device problem code 1537 ("Reuse") should be entered in F10 along with any other applicable device Note: At least 1 HECC and 1 DPC code is REQUIRED
and/or patient-related codes.
H6 Health Effect - Clinical Code
H6 Health Effect - Impact Code
H6 Medical Device Problem Code
H6 Component Code
H6 Type of Investigation
H6 Investigation Findings
H6 Investigation Conclusions
H7 If remedial action initiated, check type Indicate the applicable action(s). If other, specify the type of action in the space provided. Most of these terms are Please look at the attached vocabulary. Choose an appropriate code.
defined or further explained in the Act or in the FDA regulations concerning remedial action (see 21 USC 360h and
21 CFR Parts 7, 803 and 806).
H7 If remedial action initiated, check type\ Use 'originalText' to explain 'Other'

Explanation for Other
23
H8 Usage of device Indicate whether the use of the suspect medical device was the initial use, reuse, or unknown. Please look at the attached vocabulary. Choose an appropriate code.
If a manufacturer receives an adverse event report that indicates that the event was caused by or contributed to by
reuse of a single use device they manufactured, this block is to be appropriately marked and the facts of the firm's
investigation provided with an explanation of how the reuse of the product contributed to the outcome. The
appropriate manufacturer Result codes for reuse are also to be entered into H6.
H9 If action reported to FDA under 21 USC 360i(f), Enter the number that FDA assigned to the corrective action. If a number has not yet been assigned by FDA, the Please look at the attached vocabulary. Choose an appropriate code. Populate
list correction/removal reporting number number assigned by the firm for the action may be used. removal reporting number under 'value'
H10/H11 Additional manufacturer narrative Enter any additional information, evaluation, or clarification of data presented in previous sections. Do not duplicate Additional information can be included in the manufacturer narrative text or as
information that has already been provided elsewhere. embedded files as described in section H2 above. If you have additional
information that can be provided as a discrete data element on the 3500A form,
please provide it with the appropriate tags. For example, if you would like to
add/append/change device problem codes, please do not include it as part of
'originalText' under H10. Instead, include it in the document where you would
normally provide device problem codes with right xml tags attached.
24
Field Lengths
emental reports are allowed to
from the initial report, so the
VARCHAR2(6)
VARCHAR2(10)
VARCHAR2(10)
DATE
NUMBER(5)
VARCHAR2(10)
NUMBER(3)
25
Field Lengths
DATE
DATE
DATE
LONG (up to a maximum

of 32765 characters)
26
Field Lengths


Number(2)
Valid numbers are
1 thru 20
VARCHAR2(4)
VARCHAR2(35)
VARCHAR2(35)
VARCHAR2(500 CHAR)
VARCHAR2(500 CHAR)
VARCHAR2(100 CHAR)
VARCHAR2(100 CHAR)
VARCHAR2(500 CHAR)
Number (7,3)
27
Field Lengths
Number (3,2)
Number (3)
DATE
DATE
VARCHAR2(500 CHAR)
VARCHAR2(80)
VARCHAR2(80)
VARCHAR2(3)
VARCHAR2(50)
VARCHAR2(30)
VARCHAR2(30)
VARCHAR2(30)
VARCHAR2(2)
VARCHAR2(5)
VARCHAR2(4)
VARCHAR2(10)
VARCHAR2(50)
VARCHAR2(26)
28
Field Lengths
VARCHAR2(80)
VARCHAR2(30)
VARCHAR2(30)
DATE
VARCHAR2(30)
VARCHAR2(150)
VARCHAR2(40)
DATE
DATE
VARCHAR2(80)
VARCHAR2(30)
VARCHAR2(30)
VARCHAR2(30)
VARCHAR2(2)
VARCHAR2(5)
VARCHAR2(4)
VARCHAR2(10)
VARCHAR2(50)
VARCHAR2(26)
29
Field Lengths
DATE
VARCHAR2(50)
DATE
VARCHAR2(15)
VARCHAR2(15)
VARCHAR2(25)
VARCHAR2(4)
VARCHAR2(60)
VARCHAR2(30)
VARCHAR2(30)
VARCHAR2(30)
VARCHAR2(2)
VARCHAR2(5)
VARCHAR2(4)
VARCHAR2(10)
VARCHAR2(50)
VARCHAR2(26)
VARCHAR2(3)
VARCHAR2(1)
VARCHAR2(21)
VARCHAR2(60)
VARCHAR2(30)
VARCHAR2(30)
VARCHAR2(30)
VARCHAR2(2)
VARCHAR2(5)
30
Field Lengths
VARCHAR2(4)
VARCHAR2(10)
VARCHAR2(25)
VARCHAR2(15)
VARCHAR2(1)
VARCHAR2(4)
VARCHAR2(50)
VARCHAR2
DATE
NUMBER(3)
NUMBER(5)
VARCHAR2(10)
DATE
31
Field Lengths
VARCHAR2(40)
DATE
VARCHAR2(50)
VARCHAR2(30)
VARCHAR2(30)
VARCHAR2(30)
VARCHAR2(2)
VARCHAR2(5)
VARCHAR2(4)
VARCHAR2(10)
VARCHAR2(50)
VARCHAR2(26)
VARCHAR2(4)
VARCHAR2(15)
VARCHAR2(15)
VARCHAR2(25)
VARCHAR2(60)
VARCHAR2(30)
VARCHAR2(30)
VARCHAR2(30)
VARCHAR2(2)
VARCHAR2(5)
VARCHAR2(4)
VARCHAR2(10)
VARCHAR2(50)
VARCHAR2(26)
VARCHAR2
32
Field Lengths
VARCHAR2(40)
DATE
VARCHAR2(12)
33
Field Lengths
NUMBER(3)
VARCHAR2(300)
VARCHAR2(21)
34
Field Lengths
DATE
VARCHAR2(40)
35
Field Lengths
VARCHAR2(24)

36
FDA\CDRH\OSB HL7 ICSR Vocabulary 03/23/2023
Med Watch Med Watch Form Label MAUDE Values Vocabulary Source (OID) Concept Code Concept Preferred Term (PT)
Form Ref # NCI:
2.16.840.1.113883.3.26.1.1
FDA: 2.16.840.1.113883.3.24
Not on Form V3NORMED_2016

Applicable Fields No Code ASKU
Required
Applicable Fields No Code NI
Required
Applicable Fields No Code NA
Required
Type of Reporter NCI Type_of_Reporter

User Facility NCI C53567 User Facility
Manufacturer NCI C53616 Manufacturer
Importer NCI C53617 Importer
Type of Manufacturer NCI

OEM NCI C53618 Original_Equipment_Manufacturer
Reprocessor NCI C53614 Reprocessor
A2 Age NCI C25150 Age
A3 Gender NCI
Male NCI C20197 Male
Female NCI C16576 Female
Transgender NCI C154421 Transgender

Intersex NCI C45908 Intersex
Prefer Not to Disclose NCI C132222 Prefer Not to Disclose

A4 Weight TEXT NCI C25208 Weight
A5 Ethnicity NCI
Hispanic/Latino NCI C17459 Hispanic or Latino
Not Hispanic/Latino NCI C41222 Not Hispanic or Latino
A6 Race NCI C17049 Race
NCI C16352 Black or African American
NCI C41259 American Indian or Alaska Native
NCI C41260 Asian
NCI C41219 Native Hawaiian or Other Pacific Islander
NCI C41261 White
37
Form Ref # NCI:
2.16.840.1.113883.3.26.1.1
FDA: 2.16.840.1.113883.3.24
B1 Adverse Event Or Product Problem Report Adverse event NCI C41331 Adverse_Event
Product Problem NCI C53054 Product_Problem
Reported issue is both an adverse event FDA F55555 Adverse_Event and Product Problem
and Product Problem
B2 Outcomes Attributed to Adverse Event NCI C49489 Adverse_Event_Outcome
LIFE THREATENING NCI C41337 Life_Threatening_Adverse_Event
HOSPITALIZATION NCI C25179 Hospitalization

DISABILITY NCI C21007 Disability
CONGENITAL ANOMALY NCI C2849 Congenital_Abnormality
REQUIRED INTERVENTION NCI C52668 Intervention_Required
OTHER NCI C17649 Other

DEATH NCI C28554 Death
B6 Relevant Tests/Lab Data TEXT NCI C36292 Test_Result
B7 Other Relevant History, Including Preexisting Medical TEXT NCI C53263 Other_Personal_Medical_History
Conditions (e.g., allergies,
race, pregnancy, smoking and alcohol use,
hepatic/renal dysfunction, etc.)
C3 Dose Unit ICSH-M2 Code
C3 Frequency Unit ICSH-M2 Code
C3 Route Used ICSH-M2 Code
38
Form Ref # NCI:
2.16.840.1.113883.3.26.1.1
FDA: 2.16.840.1.113883.3.24
C5 Diagnosis Use For NCI C41184 Indication
C6 Product Type
OTC NCI C54068 OTC
Compounded NCI C94031 Compounded
Generic NCI C151960 Generic
Biosimilar NCI Biosimilar
C156644
PreANDA NCI C73584 Marketed under Abbreviated New Drug

Application
Pre1938 NCI C93630 Pre-1938 Indicator
C8 Event Abated After Use Stopped or Dose Reduced? NCI C86045 Abate
C9 Event reappeared after reintroduction NCI C54055

D2 Type of Device Acceptable MAUDE Product codes are FDA Type_of_Device
available at
http://www.fda.gov/cdrh/prodcode.html is a
downloadable zip file
D4 Unique Device Identifier (UDI) # FDA Unique Device Identifier (UDI) #
D5 Operator of Device NCI C53272 Operator_of_Medical_Device

HEALTH PROFESSIONAL NCI C53287 Health_Care_Professional
PATIENT/CONSUMER NCI C16960 Patient

D7 Is this a single use device that was reprocessed and NCI C53563 Single-
reused on a patient ? Use_Device_Reprocessed_and_Reused_on_
Patient
D8 Was this Device Serviced by Third Party? NCI C85488 Service Occupation
D9 Device Available for Evaluation? NCI C53449 Device Available for Evaluation
D9 Part 1 Returned to Manufacturer
D9 Part 2 Date of Device returned to Manufacturer NCI C53481

Date_of_Device_Return_to_Manufacturer
D10 Concomitant Medical Products and Therapy Dates TEXT NCI C53630 Concomitant_Therapy
E3 Occupation NCI Occupation
ADMINISTRATOR/SUPERVISOR NCI C134832 Administrator/Supervisor

BIOMEDICAL ENGINEER NCI C51960 Biomedical_Engineer
DENTIST NCI C52654 Dentist
NURSE NCI C20821 Nurse
39
Form Ref # NCI:
2.16.840.1.113883.3.26.1.1
FDA: 2.16.840.1.113883.3.24
NURSE PRACTITIONER NCI C20852 Nurse Practitioner
NON-HEALTHCARE PROFESSIONAL NCI C134833 Non-Healthcare Professional

OTHER HEALTH CARE PROFESSIONAL NCI C53289 Other_Health_Care_Professional
PHARMACIST NCI C51840 Pharmacist
PHYSICIAN NCI C25741 Physician

PHYSICIAN ASSISTANT NCI C53423
Physician_Assistant
THIRD PARTY SERVICER NCI C85488 Third_Party_Servicer

RISK MANAGER NCI C53448 Risk_Manager
F7 Type of Report NCI C53571 Type_of_Report
Initial - initial report of an adverse event NCI C53620 Initial_Adverse_Event_and_Product_Problem_

Report
Follow-up - follow-up report to an initial NCI C53579 Follow-Up_Report
report
F9 Approximate Age of Device TEXT NCI C53451
Approximate_Age_of_Device
F10 part 1 Health Effect - Clinical Code Currently available at FDA C53983 Patient_Problem_Code
https://www.fda.gov/MedicalDevices/Devic
eRegulationandGuidance/PostmarketReq
uirements/ReportingAdverseEvents/
MDRAdverseEventCodes/ucm584205.htm
F10 part 2 Medical Device Problem Code Currently available at FDA C53982 Device_Problem_Code
https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
PostmarketRequirements/
ReportingAdverseEvents/
F10 part 3 Component code Currently available at FDA C54577 Component Code
F10 part 4 Health Effect - Impact Code Currently available at FDA C122929 Impact Code
F11/F13 Report Receiver NCI Report_Receiver

FDA NCI C17237 Food_and_Drug_Administration
Manufacturer NCI C53616 Manufacturer
F12 Location where event occurred NCI Location_Where_Event_Occurred
AMBULATORY SURGICAL FACILITY NCI C51945 Ambulatory_Surgical_Facility
HOME NCI C18002 Home
40
Form Ref # NCI:
2.16.840.1.113883.3.26.1.1
FDA: 2.16.840.1.113883.3.24
HOSPITAL NCI C16696 Hospital
NURSING HOME NCI C53533 Nursing_Home

OUTPATIENT DIAGNOSTIC FACILITY NCI C53548 Outpatient Diagnostic Facility
OUTPATIENT TREATMENT FACILITY NCI C53549 Outpatient_Treatment_Facility
G2 Report Source (type) NCI C53566 Report_Source
COMPANY REPRESENTATIVE NCI C51968 Company_Representative
CONSUMER NCI C53568 Consumer
DISTRIBUTOR/IMPORTER NCI C48289 Distributor
FOREIGN NCI C25512 Foreign
HEALTH PROFESSIONAL NCI C53287 Health_Care_Professional
LITERATURE NCI C48471 Publication

STUDY NCI C15206 Clinical_Study
USER FACILITY NCI C53567 User_Facility

G4 Combination Product Combination Product NCI C54696 Combination Product
G6 Type of Report C53571 Type_of_Report

Five-day NCI C53573 Five-Day_Report
Seven-day NCI C53574 Seven-Day_Report

Fifteen-day NCI C53576 Fifteen-Day_Report
Thirty-day NCI C53577 Thirty-Day Report
Initial NCI C53620 Initial_Adverse_Event_and_Product_Problem_
Report
Periodic NCI C53578 Periodic_Report
Follow-up NCI C53579 Follow-up_Report
H1 Part 1 Type of reportable event NCI C53570 Type_of_Reportable_Event
Death NCI C28554 Death
Serious Injury NCI C53569 Serious_Injury
Malfunction NCI C25745 Failure

Summary Report NCI C84831 Summary_Report
H2 Type of follow-up NCI C53584 Type_of_Follow-Up_Report

Correction NCI C53585 Correction_Report
Additional information NCI C53586 Additional_Information_Report
Response to FDA request NCI C53587 Response_to_FDA_Request
Device Evaluation NCI C53588 Device_Evaluation_Report
H3 part 1 Device Evaluated by Manufacturer? NCI C53629 Device_Evaluated_by_Manufacturer
H3 part 2 Evaluation Summary status attached? NCI C53592 Evaluation_Summary_Status
H3 part 3 Reason for Non-Evaluation NCI C53593 Reason_for_Non-Evaluation
41
Form Ref # NCI:
2.16.840.1.113883.3.26.1.1
FDA: 2.16.840.1.113883.3.24
Device received in a condition which made NCI C53598 Device_Received_in_Condition_Which_Made

analysis impossible _Analysis_Impossible
Device evaluation anticipated, but not yet NCI C53601 Device_Evaluation_Anticipated_But_Not_Yet_

begun Begun
Device not made by company NCI C53599 Device_Not_Made_by_Company
Device problem already known, no NCI C53600 Device_Problem_Already_Known_No_Evaluat

evaluation necessary ion_Necessary
Other NCI C17649 Other
H3 part 4 Device Not Returned to Manufacturer for Evaluation? NCI C53591 Device_Returned_to_Manufacturer_for_Evalu
ation
H5 Device Labeled for Single Use? NCI C53602 Device_Labeled_for_Single_Use

H6 Part 1 Health Effect - Clinical Code Currently available at FDA C53983 Patient_Problem_Code
H6 Part 2 Medical Device Problem Code Currently available at FDA C53982 Device_Problem_Code
H6 Part 3 Component Code Currently available at NCI C54577 FDA Device Component Code Hierarchy
H6 Part 4 Health Effect - Impact Code Currently available at NCI C122929 Impact Code
H6 Part 5 Type of Investigation ReportingAdverseEvents/
Currently available at NCI C53984 Evaluation_Code_Method
H6 Part 6 Investigation Findings Currently available at NCI C53985 Device Evaluation Result
H6 Part 7 Investigation Conclusions Currently available at NCI C53986 Device Evaluation Conclusion
H7 Type of remedial action NCI C53603 Type_of_Remedial_Action
INSPECTION NCI C53604 Inspection
MODIFICATION/ADJUSTMENT NCI C53606 Modification_or_Adjustment
NOTIFICATION NCI C25297 Notification
PATIENT MONITORING NCI C53607 Patient_Monitoring
RELABELING NCI C53608 Relabeling
RECALL NCI C53609 Recall
REPLACE NCI C53610 Replacement
REPAIR NCI C53611 Repair
H8 Usage of Device NCI C53645 Usage_of_Device

INITIAL NCI C53612 Initial Usage
42
Form Ref # NCI:
2.16.840.1.113883.3.26.1.1
FDA: 2.16.840.1.113883.3.24
REUSE NCI C53613 Reuse

UNKNOWN NCI C17998 Unknown
H9 Corrective Action Number NCI C53619 Corrective_Action_Number
Country See Country Code Mapping
State Use State Abbreviations from

USPS
43
FDA/NCI Definition
Version code used to identify HL7 ICSR rel. 2 version (ICSR R2)
Asked but unknown. (Answer could be available but no information was provided)
No information. (No information is available for this field)
Not applicable. This question does not apply to the situation.
Device user facility means a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient
treatment facility as defined in this section, which is not a physician's office, as defined in this section. School nurse offices
and employee health units are not device user facilities.
Manufacturer means any person who manufactures, prepares, propagates, compounds, assembles, or processes a device
by chemical, physical, biological, or other procedure
Any person who imports a device into the United States and who furthers the marketing of a device from the original place
of manufacture to the person who makes final delivery or sale to the ultimate user, but who does not repackage or
otherwise change the container, wrapper, or labeling of the device or device package. If you repackage or otherwise
change the container, wrapper, or labeling, you are considered a manufacturer as defined in this section.
Original equipment manufacturer

Manufacturer of reprocessed single use devices
How long something has existed; elapsed time since birth.
The assemblage of physical properties or qualities by which male is distinguished from female; the physical difference
between male and female; the distinguishing peculiarity of male or female. (from On-line Medical Dictionary)
A person who belongs to the sex that normally produces sperm. The term is used to indicate biological sex distinctions, or
cultural gender role distinctions, or both.
A person who belongs to the sex that normally produces ova. The term is used to indicate biological sex distinctions, or
cultural gender role distinctions, or both.
A person whose gender identity or gender expression differs from their assigned sex
A person (one of unisexual specimens) who is born with genitalia and/or secondary sexual characteristics of indeterminate
sex, or which combine features of both sexes.
A response indicating that an individual prefers or preferred not to answer.
A person of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture or origin, regardless of
race. The term, "Spanish origin," can be used in addition to "Hispanic or Latino."
A person not of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture or origin, regardless
of race.
An arbitrary classification of taxonomic group that is a division of a species; usually arise as a consequence of
geographical isolation within a species and characterized by shared heredity, physical attributes and behavior, and in case
of humans, by common history, nationality, or geographic distribution.
African American; term used in the United States to categorize a population group comprised of persons having origins in
any of the black racial groups of Africa, most of whose ancestors were brought from Africa to the Americas as slaves
between the sixteenth and nineteenth centuries. Includes population subgroups, e.g. Kenyan, Nigerian, or Haitian. The
concept refers also to individuals who classify themselves as described.
A person having origins in one of the indigenous peoples of North America, who lived on the continent prior to the
European colonization. The term includes individuals belonging to a large number of tribes, states, and ethnic groups,
many of them still enduring as communities.
A person having origins in any of the original peoples of the Far East, Southeast Asia, or the Indian subcontinent, including
Cambodia, China, India, Japan, Korea, Malaysia, Mongolia, Pakistan, the Philippine Islands, Thailand, and Vietnam.
A person having origins in any of the original peoples of Hawaii, Guam, Samoa, or other Pacific Islands. The term covers
particularly people who identify themselves as part-Hawaiian, Native Hawaiian, Guamanian or Chamorro, Carolinian,
Samoan, Chuukese (Trukese), Fijian, Kosraean, Melanesian, Micronesian, Northern Mariana Islander, Palauan, Papua
New Guinean, Pohnpeian, Polynesian, Solomon Islander, Tahitian, Tokelauan, Tongan, Yapese, or Pacific Islander, not
specified.
A person with European, Middle Eastern, or North African ancestral origin who identifies, or is identified, as White.
44
FDA/NCI Definition
Any unfavorable or unintended symptom, sign, or disease (including abnormal lab) temporally associated with the use of a
medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. Such
events can be intervention related, dose related, route related, patient related, or caused by an interaction with another
drug(s) or procedure(s).
An issue with quality, authenticity, performance, or/and safety of medication or medical device. The concept encompasses
any problems that may occur during manufacturing, shipping, storage, or use of the medical product including but not
limited to such concerns as suspect counterfeit product, product contamination, super potent or subpotent medication,
defective item or its component, poor packaging or product confusion, questionable stability, device failure or malfunction,
and labeling concerns.
Temporary use of vocabulary to allow submitters to identify a reported issue as both an adverse event and a product
problem. Schema will change in future ICSR releases to identify these type of issues.
A condition or event that is attributed the adverse event.
An adverse event, and/or its immediate sequelae, which is associated with an imminent risk of death or which is
associated with physical or mental disabilities that affect or limit the ability of a person to perform activities of daily living
(eating, ambulation, toileting, etc.) See NCI Common Terminology Criteria for Adverse Events.
The condition of being treated as a patient in a hospital.
Any physical, mental, or functional impairment that limits a major activity. It may be partial or complete. (Taber's)
Any abnormality, anatomical or biochemical, evident at birth or during the neonatal period.
A patient condition when action or ministration whose purpose is to improve health or to alter the course of a disease is
considered essential and mandatory in order to prevent permanent
impairment or damage.
Different than the one(s) previously specified or mentioned.
The absence of life or state of being dead.
The outcome of a laboratory test.
Relevant elements of medical history, including preexisting medical conditions, events and facts (e.g., allergies, race,
pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.) not listed in MedWatch form.
Provide 3-digit ICSH-M2 code for Dose Unit

001 kg kilogram(s)
002 G gram(s)
003 Mg milligram(s)
004 μg microgram(s)
005 ng nanogram(s)
006 pg picogram(s)
007 mg/kg milligram(s)/kilogram
008 μg/kg microgram(s)/kilogram
009 mg/m2 milligram(s)/sq. meter
010 μg/ m2 microgram(s)/ sq. meter
011 l litre(s)
012 ml millilitre(s)
Provide 3-digit ICSH-M2 code for Frequency Unit
013 μl microlitre(s)
807
014 Seconds
Bq becquerel(s)
806 Minutes
015 GBq gigabecquerel(s)
805
016 Hours
MBq megabecquerel(s)
804
017 Days
Kbq kilobecquerel(s)
803
018 Weeks
Ci curie(s)
802
019 Months
MCi millicurie(s)
801
020 Years
μCi microcurie(s)
021 NCi nanocurie(s)
022 Mol mole(s)
023 Mmol millimole(s)
024 μmol micromole(s)
025 Iu international unit(s)
Provide
026 Kiu 3-digit ICSH-M2 code for Route Used
iu(1000s)
001
027 Auricular (otic)
Miu iu(1,000,000s)
002
028 Buccal
iu/kg iu/kilogram
003
029 Cutaneous
Meq milliequivalent(s)
004
030 Dental
% percent
005
031 Endocervical
Gtt drop(s)
006
032 Endosinusial
DF dosage form
007 Endotracheal
008 Epidural
009 Extra-amniotic
010 Hemodialysis 45
011 Intra corpus cavernosum
012 Intra-amniotic
013 Intra-arterial
014 Intra-articular
015 Intra-uterine
FDA/NCI Definition
A sign, signal, circumstance, or symptom which serves to indicate or point out the cause, pathology, treatment, or issue of
an attack of disease; the basis for initiation of a treatment for a disease or of a diagnostic test (causal, or symptomatic, or
disease-specific indication).
A medicine or device that can be bought without a doctor's order or prescription.

A medicine or device that is compounded
Generic Drug
A biological product that is highly similar in structure and function to, and has no clinically meaningful differences from, an
FDA-approved reference product.
A category specifying that a product is marketed under an Abbreviated New Drug Application
Specifies whether the entity qualifies under the 1938 Grandfather Clause, contained in section 20l(p)(l) of the U.S. Federal
Food, Drug and Cosmetic Act.
Become less in amount or intensity.(WordNet)
Event reappearing after reintroduction

Use the product code that your company assigned to the device at time of approval or clearance. This is the generic
category of medical device within the device classification established by FDA. Provide both product code and Common
Device Name. Populate the product code in the within the 'code' element. Concept code is not used for this element.
An identifier that adequately identifies a device through its distribution and use by meeting the requirements of 21 CFR
830.20 of this chapter. A unique device identifier is composed of a (1) device identifier and (2) production identifier.2 21
CFR 801.3. For more information regarding UDI, refer to the following FDA link:
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM410439.pdf
An individual who handles and controls the functioning of medical device.
A person qualified to be engaged in activity directed at preservation of mental and physical health by diseases prevention
and treatment as a source of livelihood.
A person who receives medical attention, care, or treatment, or who is registered with medical professional or institution
with the purpose to receive medical care when necessary.
An original device that has previously been used on a patient and has been subjected to additional processing and
manufacturing for the purpose of an additional single use on a patient. The subsequent processing and manufacture of a
reprocessed single-use device shall result in a device that is reprocessed within the meaning of this definition. (FDA
definition)
An occupation which provides a service to others rather than creating a product.
Indicates whether the device is available for evaluation by the manufacturer.
This is text that should include any drugs, devices, or other therapies that the patient was using. If you do not know the
date of therapy, but you know frequency, include in this section.
The principal activity that a person does to earn money. Occupation is not a required field.
NOTE: The information you provide for occupation title will not be used in any downstream systems.
NOTE: Please do not use any occupation codes that has been retired. Any retired occupation code found in the
submission will be rejected
An individual who is responsible for managing or operating a business, organization, team or department.
An individual whose profession is to apply engineering principles to understand, modify, or control biologic systems, as well
as design and manufacture products that can monitor physiologic functions and assist in the diagnosis and treatment of
patients.
An individual licensed for the prevention, diagnosis, and treatment of diseases in the oral cavity, adjacent tissues, and
related structures.
A professional healthcare provider who has graduated from an accredited nursing program, has passed the state exam for
licensure, and been registered or licensed to practice by a state authority. Nurses are educationally prepared as functional
(LPN/LVN) or professional (RN).
46
FDA/NCI Definition
A registered nurse (RN) with advanced training in diagnosing and treating illness. NPs are master's degree prepared
health experts that focus on helping patients achieve total health and prevent disease. NPs focus on disease prevention,
wellness, and patient education. NPs prescribe medications, treat illness, and perform physical examinations. NPs can
function independently of physician intervention, but require a practice agreement with a physician. NPs are licensed by a
state authority
An individual qualified in a profession outside the healthcare field.

Health care professional other than listed in section D5 of FDA MedWatch form 3500A.
A person trained in pharmacy who prepares and dispenses drugs prescribed by physicians and health practitioners. The
responsibilities include instructing patients on the use, hazards, interactions, and side effects of any drug dispensed.
Additionally, computerized and detailed records of patient drug use and medical profiles are maintained to eliminate
dangerous drug interactions and to ensure accuracy of use.
Individuals licensed to practice medicine.
A person trained and qualified to provide comprehensive diagnostic, preventive, and therapeutic medical care and services
to patients under the guidance of the physician. A scope of physician assistant professional activity does not include the
full range of interpretation
of medical findings requiring the full professional background of the licensed physician.
An occupation which provides a service to others rather than creating a product.
A person trained and licensed to implement and oversight health care risk management programs aimed on assuring
greater patient safety in health care facility or institution. The main thrust of the risk manager activity is in identifying
incidents occurring in the health care organization, which have an outcome of patient injury and may reflect error in the
course of the delivery of health care services, adverse incidents reporting, tracking, trending and elaboration of risk
reduction and risk prevention strategies and measures.
Initial report of adverse event
A report that represents follow-up information to an initial report
A publicly or privately owned institution which is primarily established and licensed for the purpose of providing elective
surgical treatment of outpatients whose recovery, under normal and routine circumstances, will not require inpatient care.
Such facility as herein defined does not include the offices of private physicians or dentists whether practicing individually
or in groups.
A person's permanent place of residence.
47
FDA/NCI Definition
An institution that provides medical, surgical, or psychiatric care and treatment for the sick or the injured.
A person appointed by the company to speak on its behalf and/or to provide defined service and work
A person who uses goods or services.
A person or group with authority to allot or deal out or apportion.
Not belonging to that in which it is contained; introduced from an outside source.
A person qualified to be engaged in activity directed at preservation of mental and physical health by diseases prevention
and treatment as a source of livelihood.

Research conducted with human subjects or on material of human origin in which an investigator directly interacts with
human subjects; includes development of new technologies, mechanism of human diseases, therapy, clinical trials,
epidemiology, behavior and health services research.
A product comprised of two or more regulated components, i.e., drug and device, biologic and device, that are physically,
chemically, or otherwise combined or mixed and produced as a single entity; or two or more separate products packaged
together in a single package or as a unit and comprised of drug and device products, device and biological products, or
biological and drug products; or a drug, device, or biological product packaged separately that according to its
investigational plan or proposed labeling is intended for use only with an approved individually specified drug, device, or
biological product where both are required to achieve the intended use, indication, or effect and where upon approval of
the proposed product the labeling of the approved product would need to be changed, e.g., to reflect a change in intended
use, dosage form, strength, route of administration, or significant change in dose; or any investigational drug, device, or
biological product packaged separately that according to its proposed labeling is for use only with another individually
specified investigational drug, device, or biological product where both are required to achieve the intended use, indication,
or effect.
Reports on events that require remedial action to prevent an unreasonable risk of substantial harm to the public health and
other types of events designated by FDA
Not used for MDR reporting
Not used for MDR reporting
Typical 30-Day MDR
Initial report of adverse event
For future MDR use
The absence of life or state of being dead.
The loss of the ability to function normally; something that does not accomplish its intended purpose.
48
FDA/NCI Definition
Terminology used for device components or accessories in safety reports and FDA CDRH documents during both pre and
post approval periods of device development and usage.
The effect or consequence of an event or condition
Device Evaluation Result
Device Evaluation Conclusion
Informing by words.
Preceding all others in time or space or degree.

49
FDA/NCI Definition
Not known, not observed, not recorded, or refused.

Number assigned to an action reported to FDA under 21 USC 260(f).
Current CDRH Implementation will support both 2 character and 3 character country codes. Please refer to the
countryCodeMapping sheet.
Please refer to http://www.usps.com/ncsc/lookups/abbreviations.html#states for appropriate state codes for United States
50
FDA\CDRH\OSB HL7 ICSR X_path mapping to MedWatch 3500A 03/23/2023
Med Watch
Form Ref # MedWatch Field/Section Name
Version Code
Batch ID
Message ID
Form Source
Exemption Number
Attachment Filename
Attachment
A Patient Information
A1 Patient Identifier
A2 Date of birth
A2 Age at time of event
A2 Age at time of event Unit
A3 Gender
A4 Weight
A4 Weight Unit
A5 Ethnicity
A6 Race
B Adverse Event or Product Problem
Type of Report
B1
Outcomes attributed to adverse event
B2
B2 Date of Death
B3 Date of Event
B4 Date of this report
B5 Describe event or problem
B6 Relevant tests/laboratory data
Other relevant history, including
B7 preexisting medical conditions
C Suspect Product(s)
C Drug Sequence Number
C Drug Type
C Approval Number
C (& G6) If IND/PreANDA, Give Protocol #
C1 Name and Strength
C1 Manufacturer/Compounder
51
Med Watch
C1 NDC # or Unique ID
C1 Lot #
C3 Dose
C3 Dose Unit
C3 Number of separate dosages
C3 Frequency
C3 Frequency Unit
C3 Route Used
Treatment Dates/Therapy Dates - Start
C4 Date
Treatment Dates/Therapy Dates - Stop
C4 Date
C5 Diagnosis Use For
C6 Product Type
C6 OTC
C6 Compounded
C6 Generic
C6 Biosimilar
C6 PreANDA
C6 Pre1938
C7 Expiration date
Event Abated After Use Stopped or
C8 Dose Reduced?
Event Reappeared After Reintroduction
C9
D Suspect medical device
D1 Brand Name
D2 Type of device
D2 Device Type Name
D3 Manufacturer name & address
D3 mfr_name
D3 mfr_street_1
D3 mfr_street_2
D3 mfr_city
D3 mfr_state
D3 mfr_postalCode
D3 mfr_country
52
Med Watch
D3 email address
D3 fax number
Model #, Lot #, Catalog #, Expiration
Date, Serial #, Unique Identifier (UDI) #
D4
D4 Model Number
D4 Lot Number
D4 Catalog Number
D4 Expiration Date
D4 Serial Number
D4 Unique Identifier (UDI) #
D5 Operator of device
D5 Other Operator
D6A If Implanted give date
D6B If explanted, give date
Is this a single-use device that was
D7A reprocessed and reused on a patient?
D7B If yes to item D7A, enter name and address of reprocessor
D7B mfr_name
D7B mfr_street_1
D7B mfr_street_2
D7B mfr_city
D7B mfr_state
D7B mfr_postalCode
D7B mfr_country
D7B email address
D7B fax number
Was this device serviced by a third
D8 party?
Device available for evaluation? Date
D9 returned to Manufacturer
D9 Date returned to manufacturer
D10 Concomitant medical products
D10 Therapy dates
E INITIAL REPORTER
E1 Name and Address
E1 Reporter_First_Name
53
Med Watch
E1 Reporter_Middle_Name
E1 Report_Last_Name
E1 Title
E1 Facility name
E1 streetAddressLine
E1 streetAddressLine 2
E1 city
E1 state
E1 postalCode
E1 country
E1 email address
E1 Phone #
E1 Fax number
E2 Health Professional?
E3 Occupation
E4 Initial reporter also sent report to FDA
For use by user facility/distributor -
F devices only
F1 Check one: user facility, distributor
UF/Distributor (Importer) Report
F2 Number
User Facility or Distributor (Importer)
F3 Name/Address
F3 streetAddressLine
F3 streetAddressLine 2
F3 city
F3 state
F3 zip_code
F3 country
F4 Contact person
F4 contact_first_name
F4 contact_mi_name
F4 contact_last_name
F4 contact_title
F4 email address
F5 Phone #
54
Med Watch
Date user facility or distributor became
F6 aware of event
F7 Type of report
F7 Follow up number
F8 Date of this report
F9 Approximate age of device
F9 Approximate age of device unit
F10 Adverse Event Problem
F10 Health Effect - Clinical Code
F10 Medical Device Problem Code
F10 Component Code
F10 Health Effect - Impact Code
F11 Report sent to FDA?
F11 Date report was sent to FDA
F12 Location where event occurred
F12 Other
F13 Report sent to manufacturer?
F13 Date report was sent to manufacturer?
F14 Manufacturer name/address
F14 Manufacturer Name
F14 Manufacturer Address Street Line 1
F14 Manufacturer Address Street Line 2
F14 Manufacturer City
F14 Manufacturer State Code
F14 Manufacturer Country Code
F14 Manufacturer Postal Code
F14 Manufacturer Email
F14 Manufacturer Fax Number
G All manufacturers
G1 Contact Office (and Manufacturing Site for Devices)
G1 or Compounding Outsourcing Facility
Site Name (Mfg. - Name and Address
Site)
G1 streetAddressLine (Mfg. Site)
G1 streetAddressLine2 (Mfg. Site)
G1 city (Mfg. Site)
G1 state (Mfg. Site)
G1 postal code (Mfg. Site)
G1 country (Mfg. Site)
55
Med Watch
G1 email address (Mfg. Site)
G1 Fax number (Mfg. Site)
G1 Prefix (Contact Off.)
G1 First name (Contact Off.)
G1 Middle name (Contact Off.)
G1 Last name (Contact Off.)
G1 Site Name (Contact Off.)
G1 streetAddressLine (Contact Off.)
G1 streetAddressLine2 (Contact Off.)
G1 City (Contact Off.)
G1 State (Contact Off.)
G1 Postal code (Contact Off.)
G1 Country (Contact Off.)
G1 Email address (Contact Off.)
G1 Fax number (Contact Off.)
G1 Phone number (Contact Off.)
Contact Report source
G2
G2 Contact Report Source - Other Text
G3 Date received by manufacturer
Premarket Application Numbers and
G4 Premarket Checkboxes
G4 PMA/510k (or) BLA #
G4 Combination product
Type of report
G6
G6 Follow up number
G7 Adverse Event Terms
G8 MFR Report #
H Device manufacturers only
Type of reportable event
H1 Part 1
H1 Part 2 No. of events (NOE) summarized
H2 If follow-up, what type?
H2 Response to FDA Request
H2 Additional Information
56
Med Watch
H2 Device Evaluation
H2 Correction
H3 Device evaluated by mfr?
H3 Yes or No
(Attach page to explain why not) or
H3 provide code
Reason for Non-evaluation, explain
H3 Other
H3 Not Returned to Manufacturer
H3 Evaluation Summary Attached
H4 Device manufacture date
H5 Labeled for single use?
H6 Adverse Event Problem
H6 Health Effect - Clinical Code
H6 Medical Device Problem Code
H6 Component Code
H6 Health Effect - Impact Code
Type of Investigation
H6
H6 Investigation Findings
H6 Investigation Conclusions
If remedial action initiated, check type
H7
H8 Usage of device
If action reported to FDA under 21 USC
360i(f), list correction/removal reporting
H9 number
H10 Additional manufacturer narrative
57
X-Path
//versionCode/@code
//id[@assigningAuthorityName="MessageSender"]/@extension
//message/id/@extension
//message/controlActProcess/reasonOf/detectedIssueEvent/code[@code='F77770']/../value/@code
//message/controlActProcess/reasonOf/detectedIssueEvent/code[@code='F77776']/../value/@code
//message/attachment/text/reference/@value
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//message/controlActProcess/subject/investigationEvent/trigger/reaction/text/text()
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//message[1]/controlActProcess/subject/investigationEvent/component/adverseEventAssessment/subject1/primaryRole/subjectOf2/organizer/component/substanceAdministrat
58
X-Path
//message/controlActProcess/subject/investigationEvent/pertainsTo/procedureEvent/device/identifiedDevice/identifiedDevice/inventoryItem/manufacturedDeviceModel/manufac
//message/controlActProcess/subject/investigationEvent/pertainsTo/procedureEvent/device/identifiedDevice/identifiedDevice/inventoryItem/manufacturedDeviceModel/code/@
//message/controlActProcess/subject/investigationEvent/pertainsTo/procedureEvent/device/identifiedDevice/identifiedDevice/inventoryItem/manufacturedDeviceModel/code/ori
//message/controlActProcess/subject/investigationEvent/pertainsTo/procedureEvent/device/identifiedDevice/identifiedDevice/asManufacturedProduct/manufacturerOrReproces
59
X-Path
//message/controlActProcess/subject/investigationEvent/pertainsTo/procedureEvent/device/identifiedDevice/identifiedDevice/inventoryItem/manufacturedDeviceModel/id/@ext
//message/controlActProcess/subject/investigationEvent/pertainsTo/procedureEvent/device/identifiedDevice/identifiedDevice/lotNumberText/text()
//message/controlActProcess/subject/investigationEvent/pertainsTo/procedureEvent/device/identifiedDevice/identifiedDevice/asManufacturedProduct/id/@extension
//message/controlActProcess/subject/investigationEvent/pertainsTo/procedureEvent/device/identifiedDevice/identifiedDevice/expirationTime/@value
//message/controlActProcess/subject/investigationEvent/pertainsTo/procedureEvent/device/identifiedDevice/identifiedDevice/id/@extension
//message/controlActProcess/subject/investigationEvent/pertainsTo/procedureEvent/device/identifiedDevice/identifiedDevice/asManufacturedProduct[1]/code/@code
//message/controlActProcess/subject/investigationEvent/pertainsTo/procedureEvent/authorOrPerformer/assignedEntity/code/@code
//message/controlActProcess/subject/investigationEvent/pertainsTo/procedureEvent/authorOrPerformer/assignedEntity/code/originalText/text()
//message/controlActProcess/subject/investigationEvent/pertainsTo/procedureEvent/component1/implantation/effectiveTime/@value
//message/controlActProcess/subject/investigationEvent/pertainsTo/procedureEvent/component2/explantation/effectiveTime/@value
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address of reprocessor
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//message/controlActProcess/subject/investigationEvent/pertainsTo/procedureEvent/device/identifiedDevice/subjectOf/deviceObservation/code[@code='C53449']/../value/@va
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//message/controlActProcess/subject/investigationEvent/pertainsTo[1]/procedureEvent/pertinentInformation1/observation[1]/code[@code='C53630']/../effectiveTime/@value
//message/controlActProcess/subject/investigationEvent/trigger/reaction/pertinentInformation/primarySourceReport/author/assignedEntity/assignedPerson/name/given[1]/text()
60
X-Path
//message/controlActProcess/subject/investigationEvent/trigger/reaction/pertinentInformation/primarySourceReport/author/assignedEntity/assignedPerson/name/given[2]/text()
//message/controlActProcess/subject/investigationEvent/trigger/reaction/pertinentInformation/primarySourceReport/author/assignedEntity/assignedPerson/name/family/text()
//message/controlActProcess/subject/investigationEvent/trigger/reaction/pertinentInformation/primarySourceReport/author/assignedEntity/assignedPerson/name/prefix/text()
//message/controlActProcess/subject/investigationEvent/trigger/reaction/pertinentInformation/primarySourceReport/author/assignedEntity/representedOrganization/name/text()
//message/controlActProcess/subject/investigationEvent/trigger/reaction/pertinentInformation/primarySourceReport/author/assignedEntity/assignedPerson/addr/streetAddressL
//message/controlActProcess/subject/investigationEvent/trigger/reaction/pertinentInformation/primarySourceReport/author/assignedEntity/assignedPerson/addr/streetAddressL
//message/controlActProcess/subject/investigationEvent/trigger/reaction/pertinentInformation/primarySourceReport/author/assignedEntity/assignedPerson/addr/city/text()
//message/controlActProcess/subject/investigationEvent/trigger/reaction/pertinentInformation/primarySourceReport/author/assignedEntity/assignedPerson/addr/state/text()
//message/controlActProcess/subject/investigationEvent/trigger/reaction/pertinentInformation/primarySourceReport/author/assignedEntity/assignedPerson/addr/postalCode/tex
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//message/controlActProcess/subject/investigationEvent/trigger/reaction/pertinentInformation/primarySourceReport/author/assignedEntity/assignedPerson/telecom[starts-with(@

//message/controlActProcess/subject/investigationEvent/trigger/reaction/pertinentInformation/primarySourceReport/author/assignedEntity/code/@code
//message/controlActProcess/subject/investigationEvent/trigger/reaction/pertinentInformation/primarySourceReport/receiver/@negationInd
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//message/controlActProcess/subject/investigationEvent/pertinentInformation1/secondaryCaseNotification/id/@extension
//message/controlActProcess/subject/investigationEvent/pertinentInformation1/secondaryCaseNotification/author/assignedEntity/assignedOrganization/addr/additionalLocator/t
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//message/controlActProcess/subject/investigationEvent/pertinentInformation1/secondaryCaseNotification/author/assignedEntity/assignedOrganization/addr/postalCode/text()
//message/controlActProcess/subject/investigationEvent/pertinentInformation1/secondaryCaseNotification/author/assignedEntity/assignedOrganization/addr/country/text()
//message/controlActProcess/subject/investigationEvent/pertinentInformation1/secondaryCaseNotification/author/assignedEntity/assignedOrganization/contactParty/contactPe
61
X-Path
//message/controlActProcess/subject/investigationEvent/pertinentInformation1/secondaryCaseNotification/effectiveTime/@value
//message/controlActProcess/subject/investigationEvent/pertinentInformation1/secondaryCaseNotification/code/@code
//message/controlActProcess/subject/investigationEvent/pertinentInformation1/sequenceNumber/@value
<--! This will be inferred from F11 or F13 value -->
//message/controlActProcess/subject/investigationEvent/pertainsTo[1]/procedureEvent/device/identifiedDevice/subjectOf/deviceObservation/code[@code='C53451']/../value/@
//message/controlActProcess/subject/investigationEvent/trigger/reaction/subject/investigativeSubject/subjectOf/observation/code[@code='C53983']/../value/@code
//message/controlActProcess/subject/investigationEvent/pertainsTo/procedureEvent/device/identifiedDevice/subjectOf/deviceObservation/code[@code='C53982']/../value/@co
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//message/controlActProcess/subject/investigationEvent/pertinentInformation1[2]/secondaryCaseNotification/receiver/assignedEntity/assignedOrganization/addr/state/text()
//message/controlActProcess/subject/investigationEvent/pertinentInformation1[2]/secondaryCaseNotification/receiver/assignedEntity/assignedOrganization/addr/country/text()
//message/controlActProcess/subject/investigationEvent/pertinentInformation1[2]/secondaryCaseNotification/receiver/assignedEntity/assignedOrganization/addr/postalCode/te
//message/controlActProcess/subject/investigationEvent/pertinentInformation1[2]/secondaryCaseNotification/receiver/assignedEntity/assignedOrganization/telecom[starts-with(
//message/controlActProcess/subject/investigationEvent/pertinentInformation1[2]/secondaryCaseNotification/receiver/assignedEntity/assignedOrganization/telecom[starts-with(
Site for Devices)

y - Name and Address
//message/controlActProcess/subject/investigationEvent/pertainsTo[1]/procedureEvent/device/identifiedDevice/identifiedDevice/asManufacturedProduct/manufacturerOrReproc
62
X-Path
//message/controlActProcess/reasonOf/detectedIssueEvent/code[@code='C53566']/../value/@code
//message/controlActProcess/reasonOf/detectedIssueEvent/value[@code='C17649']/../code/originalText/text()
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63
X-Path
//message/controlActProcess/subject/investigationEvent/pertainsTo[1]/procedureEvent/device/identifiedDevice/subjectOf/deviceObservation/code[@code='C53593']/../value/or
//message/controlActProcess/subject/investigationEvent/pertainsTo[1]/procedureEvent/device/identifiedDevice/identifiedDevice/existenceTime/@value
//message/controlActProcess/subject/investigationEvent/pertainsTo/procedureEvent/device/identifiedDevice/subjectOf/deviceObservation/code[@code='C53619']/../value/text(
//message/controlActProcess/subject/investigationEvent/text/text()
64
CDRH eMDR - HL7 ICSR Implementation -- Country Code Mapping 03/23/2023
CDRH Country Code Mapping
Current CDRH implementation of HL7 ICSR will support -- 2 character FIPS/NIST country codes
and the three character GENC codes. Eventually CDRH will phase out the 2 character codes.
Below, we have provided mapping between the FIPS/NIST,GENC three character codes for your
use.
Country FIPS/NIST GENC3
AFGHANISTAN AF AFG
AKROTIRI XQZ
ALAND ISLANDS FIN
ALBANIA AL ALB
ALGERIA AG DZA
AMERICAN SAMOA ASM
ANDORRA AN AND
ANGOLA AO AGO
ANGUILLA AV AIA
ANTARCTICA AY ATA
ANTIGUA AND BARBUDA AC ATG
ARGENTINA AR ARG
ARMENIA AM ARM
ARUBA AA ABW
ASHMORE AND CARTIER ISLANDS XAC
AUSTRALIA AS AUS
AUSTRIA AU AUT
AZERBAIJAN AJ AZE
BAHAMAS BF BHS
BAHAMAS, THE BF BHS
BAHRAIN BA BHR
65
BAKER ISLAND use. FQ XBK
BANGLADESH BG BGD
BARBADOS BB BRB
BASSAS DA INDIA XBI
BELARUS BO BLR
BELGIUM BE BEL
BELIZE BH BLZ
BENIN BN BEN
BERMUDA BD BMU
BHUTAN BT BTN
BOLIVIA BL BOL
BOLIVIA (PLURINATIONAL STATE OF) BL BOL
BONAIRE, SINT EUSTATIUS, AND SABA BES
BOSNIA AND HERZEGOVINA BK BIH
BOTSWANA BC BWA
BOUVET ISLAND BV BVT
BRAZIL BR BRA
BRITISH INDIAN OCEAN TERRITORY IO IOT
BRITISH VIRGIN ISLANDS VI VGB
BRUNEI BX BRN
BRUNEI DARUSSALAM BX BRN
BULGARIA BU BGR
BURKINA UV BFA
BURKINA FASO UV BFA
BURMA MMR
66
BURUNDI use. BY BDI
CABO VERDE CV CPV
CAMBODIA CB KHM
CAMEROON CM CMR
CANADA CA CAN
CAPE VERDE CV CPV
CAYMAN ISLANDS CJ CYM
CENTRAL AFRICAN REPUBLIC CT CAF
CHAD CD TCD
CHILE CI CHL
CHINA CH CHN
CHINA (TAIWAN) TW TWN
CHRISTMAS ISLAND KT CXR
CLIPPERTON ISLAND IP CPT
COCOS (KEELING) ISLANDS CK CCK
COLOMBIA CO COL
COMOROS CN COM
CONGO CF COG
CONGO (BRAZZAVILLE) CF COG
CONGO (KINSHASA) CG COD
CONGO, DEMOCRATIC REPUBLIC OF THE CG COD
COOK ISLANDS CW COK
CORAL SEA ISLANDS XCS
COSTA RICA CS CRI
COTE D IVOIRE IV CIV
67
CROATIA use. HR HRV
CUBA CU CUB
CURACAO CUW
CYPRUS CY CYP
CZECH REPUBLIC EZ CZE
CZECHIA EZ CZE
DENMARK DA DNK
DHEKELIA XXD
DIEGO GARCIA DGA
DJIBOUTI DJ DJI
DOMINICA DO DMA
DOMINICAN REPUBLIC DR DOM
ECUADOR EC ECU
EGYPT EG EGY
EL SALVADOR ES SLV
EQUATORIAL GUINEA EK GNQ
ERITREA ER ERI
ESTONIA EN EST
ETHIOPIA ET ETH
EUROPA ISLAND EU XEU
FALKLAND ISLANDS (ISLAS MALVINAS) FK FLK
FAROE ISLANDS FO FRO
FEDERATED STATES OF MICRONESIA FM FSM
FIJI FJ FJI
FINLAND FI FIN
68
FRANCE use. FR FRA
FRENCH GUIANA FG GUF
FRENCH POLYNESIA FP PYF
FRENCH SOUTHERN AND ANTARCTIC LANDS FS ATF
FRENCH TERRITORY OF THE AFARS AND ISSAS FT
GABON GB GAB
GAMBIA GA GMB
GAMBIA, THE GA GMB
GAZA STRIP GZ XGZ
GEORGIA GG GEO
GERMANY GM DEU
GHANA GH GHA
GIBRALTAR GI GIB
GLORIOSO ISLANDS GO XGL
GREECE GR GRC
GREENLAND GL GRL
GRENADA GJ GRD
GUADELOUPE GP GLP
GUAM GUM
GUANTANAMO BAY NAVAL BASE AX2
GUATEMALA GT GTM
GUERNSEY GK GGY
GUINEA GV GIN
GUINEA-BISSAU PU GNB
GUYANA GY GUY
69
HAITI use. HA HTI
HEARD ISLAND AND MCDONALD ISLANDS HM HMD
HOLY SEE VT VAT
HONDURAS HO HND
HONG KONG HK HKG
HOWLAND ISLAND HQ XHO
HUNGARY HU HUN
ICELAND IC ISL
INDIA IN IND
INDONESIA ID IDN
IRAN IR IRN
IRAN (ISLAMIC REPUBLIC OF) IR IRN
IRAQ IZ IRQ
IRAQ-SAUDI ARABIA NEUTRAL ZONE IY
IRELAND EI IRL
ISLE OF MAN IM IMN
ISRAEL IS ISR
ITALY IT ITA
IVORY COAST IV CIV
JAMAICA JM JAM
JAN MAYEN JN XJM
JAPAN JA JPN
JARVIS ISLAND DQ XJV
JERSEY JE JEY
JOHNSTON ATOLL JQ XJA
70
JORDAN use. JO JOR
JUAN DE NOVA ISLAND JU XJN
KAZAKHSTAN KZ KAZ
KENYA KE KEN
KINGMAN REEF KQ XKR
KIRIBATI KR KIR
KOREA, DEMOCRATIC PEOPLE'S REPUBLIC OF KN PRK
KOREA, NORTH KN PRK
KOREA, REPUBLIC OF KS KOR
KOREA, SOUTH KS KOR
KOSOVO XKS
KUWAIT KU KWT
KYRGYZSTAN KG KGZ
LA REUNION RE REU
LAO PEOPLE'S DEMOCRACTIC REPUBLIC LA LAO
LAOS LA LAO
LATVIA LG LVA
LEBANON LE LBN
LESOTHO LT LSO
LIBERIA LI LBR
LIBYA LY LBY
LIECHTENSTEIN LS LIE
LITHUANIA LH LTU
LUXEMBOURG LU LUX
MACAO MC MAC
71
MACAU use. MC MAC
MACEDONIA MK MKD
MADAGASCAR MA MDG
MALAWI MI MWI
MALAYSIA MY MYS
MALDIVES MV MDV
MALI ML MLI
MALTA MT MLT
MARSHALL ISLANDS RM MHL
MARTINIQUE MB MTQ
MAURITANIA MR MRT
MAURITIUS MP MUS
MAYOTTE MF MYT
MEXICO MX MEX
MICRONESIA (FEDERATED STATES OF) FM FSM
MIDWAY ISLANDS XMW
MOLDOVA MD MDA
MOLDOVA, REPUBLIC OF MD MDA
MONACO MN MCO
MONGOLIA MG MNG
MONTENEGRO MNE
MONTSERRAT MH MSR
MOROCCO MO MAR
MOZAMBIQUE MZ MOZ
MYANMAR MMR
72
NAMIBIA use. WA NAM
NAURU NR NRU
NAVASSA ISLAND BQ XNV
NEPAL NP NPL
NETHERLANDS NL NLD
NETHERLANDS ANTILLES NT
NEW CALEDONIA NC NCL
NEW ZEALAND NZ NZL
NICARAGUA NU NIC
NIGER NG NER
NIGERIA NI NGA
NIUE NE NIU
NORFOLK ISLAND NF NFK
NORTH KOREA KN PRK
NORTHERN MARIANA ISLANDS MNP
NORWAY NO NOR
OMAN MU OMN
PAKISTAN PK PAK
PALAU PLW
PALESTINE, STATE OF GZ XGZ
PALMYRA ATOLL LQ XPL
PANAMA PM PAN
PAPUA NEW GUINEA PP PNG
PARACEL ISLANDS XPR
PARAGUAY PA PRY
73
PERU use. PE PER
PHILIPPINES RP PHL
PITCAIRN PC PCN
PITCAIRN ISLANDS PC PCN
POLAND PL POL
PORTUGAL PO PRT
PUERTO RICO PRI
QATAR QA QAT
REUNION RE REU
ROMANIA RO ROU
RUSSIA RS RUS
RUSSIAN FEDERATION RS RUS
RWANDA RW RWA
SAINT BARTHELEMY BLM
SAINT HELENA, ASCENSION, AND TRISTAN DA CUNHA SH SHN
SAINT KITTS AND NEVIS SC KNA
SAINT LUCIA ST LCA
SAINT MARTIN MAF
SAINT PIERRE AND MIQUELON SB SPM
SAINT VINCENT AND THE GRENADINES VC VCT
SAMOA WS WSM
SAN MARINO SM SMR
SAO TOME AND PRINCIPE TP STP
SAUDI ARABIA SA SAU
SENEGAL SG SEN
74
SERBIA use. SRB
SEYCHELLES SE SYC
SIERRA LEONE SL SLE
SINGAPORE SN SGP
SINT MAARTEN SXM
SINT MAARTEN (DUTCH PART) SXM
SLOVAKIA LO SVK
SLOVENIA SI SVN
SOLOMON ISLANDS BP SLB
SOMALIA SO SOM
SOUTH AFRICA SF ZAF
SOUTH GEORGIA AND SOUTH SANDWICH ISLANDS SX SGS
SOUTH KOREA KS KOR
SOUTH SUDAN SSD
SPAIN SP ESP
SPRATLY ISLANDS XSP
SRI LANKA CE LKA
ST. CHRISTOPHER AND NEVIS SC KNA
ST. HELENA SH SHN
ST. LUCIA ST LCA
ST. PIERRE AND MIQUELON SB SPM
ST. VINCENT AND THE GRENADINES VC VCT
SUDAN SU SDN
SURINAME NS SUR
SVALBARD SV XSV
75
SVALBARD AND JAN MAYEN use. SV XSV
SWAZILAND WZ SWZ
SWEDEN SW SWE
SWITZERLAND SZ CHE
SYRIA SY SYR
SYRIAN ARAB REPUBLIC SY SYR
TAIWAN TW TWN
TAIWAN, PROVINCE OF CHINA TW TWN
TAJIKISTAN TI TJK
TANZANIA TZ TZA
THAILAND TH THA
THE GAMBIA GA GMB
TIMOR-LESTE TLS
TOGO TO TGO
TOKELAU TL TKL
TOKELAU ISLANDS TL TKL
TONGA TN TON
TRINIDAD AND TOBAGO TD TTO
TROMELIN ISLAND TE XTR
TUNISIA TS TUN
TURKEY TU TUR
TURKMENISTAN TX TKM
TURKS AND CAICOS ISLANDS TK TCA
TUVALU TV TUV
UGANDA UG UGA
76
UKRAINE use. UP UKR
UNITED ARAB EMIRATES TC ARE
UNITED KINGDOM UK GBR
UNITED KINGDOM OF GREAT BRITAIN AND NORTHERN IRELAND UK GBR
UNITED REPUBLIC OF TANZANIA TZ TZA
UNITED STATES US USA
UNITED STATES OF AMERICA US USA
UNKNOWN AX1
URUGUAY UY URY
UZBEKISTAN UZ UZB
VANUATU NH VUT
VATICAN CITY VT VAT
VENEZUELA VE VEN
VENEZUELA (BOLIVARIAN REPUBLIC OF) VE VEN
VIET NAM VM VNM
VIETNAM VM VNM
VIRGIN ISLANDS, BRITISH VI VGB
VIRGIN ISLANDS, U.S. VIR
WAKE ISLAND WQ XWK
WALLIS AND FUTUNA WF WLF
WEST BANK WE XWB
WESTERN SAHARA WI ESH
WESTERN SAMOA WS WSM
YEMEN YM YEM
ZAIRE CG COD
77
ZAMBIA use. ZA ZMB
ZIMBABWE ZI ZWE
78

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eMDR HL7 Pointers - Change Log

Date Worksheet Name Medwatch Form Medwatch Field/Section Name

11/1/17 3500A_HL7_Pointers E3 - Occupation-text

2/22/18 3500A_HL7_Pointers F4 - User Facility Contact Email

2/26/18 3500A_HL7_Pointers G1 - Manufacturer Contact Facility Name

3/5/18 3500A_HL7_Pointers A4 - Weight

Date Worksheet Name Medwatch Form Medwatch Field/Section Name

3/27/18 Xpath H3 - Device Not Returned to Manufacturer

5/4/18 3500A_HL7_Pointers F9 - Approximate Age of the Device

6/1/18 3500A_HL7_Pointers G7 - Type of Report

6/13/18 3500A_HL7_Pointers H8 - Usage of device

6/13/18 xPath to Form C9 and C10

8/2/18 Vocab E3 - Occupation

Date Worksheet Name Medwatch Form Medwatch Field/Section Name

12/20/18 3500A_HL7_Pointers H3 - Part 4 - Device Not Returned to

3/20/20 Vocab Gender

3/20/20 All Tabs List Medical Product and Treatment Given

3/20/20 All Tabs N/A

3/20/20 Vocab E3 Occupation

Date Worksheet Name Medwatch Form Medwatch Field/Section Name

3/20/20 xPath to Form Component Code

8/2/20 All Tabs C6 Product Type

9/14/20 3500A_HL7_Pointers F14 Manufacturer name/address

Date Worksheet Name Medwatch Form Medwatch Field/Section Name

10/2/20 xPath to Form NA NA

8/19/22 3500A_HL7_Pointers NA Form Code

Removing from Implementation Package

Facility Name updated from VARCHAR2(50) to VARCHAR2(60)

Changed the 'lb' unit value to 'lbs'

Updated Concept Code, Concept Preferred Term and NCI definition

Updated Concept Code, Concept Preferred Term and NCI definition

Updated the User Facility Contact Email from F4 to F3

Added the instruction in pointer sheet for H3 - Part 4 field.

Updated X-Path with correct code C9 - C86045

Renamed Section Header. Old label: "Therapy Dates"

Added code C85488

Introduced new xpath and CCode ( C54577 )

Same xpath. Renamed Section Name "Patient Problem Code"

Phone number (G2) is now part of field G1

Added xpath for "Device BLA" and "Combination Product"

Replaced ISO Country Codes to FIPS/NIST and GenC Country Codes

Removed Combination Product - C54696

Modified Section reference from D9 to D7B

Renamed label from "Attachments" to "Attachment Filename" (Refer Cell C8)

Added Field Length

B Adverse Event or Product Problem

B4 Date of this Report

For Supplemental Report:

D2 Type of Device Provide Product Code and Common Device Name

Health professional = physician, nurse, respiratory therapist, etc.

D5 Operator of Device - Other Use the 'text' area to describe 'Other'

F4 User Facility Contact Last Name

F7 Type of Report\Follow-up Number Populate follow-up number under /pertinentInformation1/sequenceNumber

F10 part 1 Health Effect - Clinical Code

F10 part 2 Medical Device Problem Code

F10 part 3 Component Code

F10 part 4 Health Effect - Impact Code

G1 Manufacturer Contact Title

G6 Type of Report\Follow-up Number Preferred Use 'text' to populate 'follow-up' number

H Device manufacturers only

Summary Report: Check this option if Number of Events is a positive Integer.

H6 Health Effect - Clinical Code

H6 Health Effect - Impact Code