U.S. flag An official website of the United States government
  1. Home
  2. Medical Devices
  3. Device Advice: Comprehensive Regulatory Assistance
  4. Postmarket Requirements (Devices)
  5. Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities
  6. MDR Adverse Event Codes
  7. Coding FAQs
  1. MDR Adverse Event Codes

This page provides answers to frequently asked questions reporters may have while choosing adverse event codes for a report. It also contains additional instructions for specific codes that have unique functions in their respective hierarchies.

Device Problem Code

1. When should I use code 3189: No Apparent Adverse Event ? 
Reporters should not use this code. An event that is not an adverse event is, by definition, not a reportable adverse event. This code is for FDA use only.

Patient Problem Code

1. When should I use Patient Problem/Medical Problem?
Do not use this code. This code is a generic parent for all patient problem codes.

2. When should I use code 2199: No Consequences or Impact to Patient?
Use this code to describe reportable malfunctions involving a patient who sustained no adverse outcomes.

3. When should I use code 2645: No Patient Involvement?
Use this code to describe reportable malfunctions not involving a patient.

4. When should I use Missing Value Reason?
Do not use this code. This code is a generic parent for all missing value reason codes, which are listed below.

5. When should I use code 2692: No Known Impact or Consequence to Patient?
Do not use this code. This code will be retired during the IMDRF harmonization effort, as it is too generic. Please choose the most appropriate of code 2199: No Consequences or Impact to Patient or 2645: No Patient Involvement.

6. When should I use code 3189: Not Applicable?
Do not use this code. This code will be retired during the IMDRF harmonization effort, as it is too generic. Please choose another one of the Missing Value Reason codes.

7. When should I use code 3190: No Information?
Use this code if there is not enough information about the adverse event to assign a patient problem code.

8. When should I use code 3191: No Code Available?
Use this code if information is available to code the patient problem, but an appropriate code does not exist. Please submit a new code request according to the instructions on the main Adverse Event Codes page.

Device Component Code

1. When should I use Device Component or Accessory?
Do not use this code. This code is a generic parent for all device component codes.

2. What if I am unable to identify the associated device component, or the component does not have a corresponding device component code?
The device component code field provides valuable information to reviewers, but it is not a required field. In these situations, it is acceptable to not provide a device component code.