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  6. MDR Adverse Event Codes
  7. How to Code an MDR Adverse Event Report
  1. MDR Adverse Event Codes

How to Code an MDR Adverse Event Report

This page gives an overview of how reporters should use the MDR adverse event codes when filling out the MedWatch 3500A form.

General Instructions

In general, reporters are expected to provide at least one code for each adverse event code field that is relevant to their MDR. Note that this applies only to mandatory MDR reporting, which uses the 3500A form.

When prompted, reporters should select the lowest level, most detailed code or codes necessary to describe the event. Each parent code in the hierarchy is considered to be a set containing all of its child codes, so there is no need to choose both a parent and one of its children – the child code alone is sufficient. Depending on the submission method, the mechanics of how the reporter will choose the code will be different. For more information, see the Submission Methods section below.

There are two distinct coding scenarios; one is for manufacturers, and the other is for importers and user facilities. Depending on the type of reporter, the section of the 3500A where codes are entered and the code types required will be different.

Importers and User Facilities (F10)

Importers (or distributors) and user facilities are required to complete section F of the 3500A form, which includes adverse event problem codes in section F10. F10 prompts the reporter to specify at least one code of each type:

Code Recommendations
Medical Device Problem

Select the lowest level, most detailed code or codes that most accurately describe the device failures or problems observed during the event.

Note: Code 3189 (No Apparent Adverse Event) is for FDA use only, because this code would indicate that the event is by definition not a reportable adverse event.

Medical Device Component

Select the lowest level, most detailed code or codes that most accurately describe the device components that were involved in the failure or problem observed.

If the failure or problem cannot be linked to a specific part, component, or subassembly, select code 4755 (Part/Component/Sub-assembly Term not Applicable).

Health Effect – Clinical Signs and Symptoms or Conditions

Select the lowest level, most detailed code or codes that describe what happened to the patient as a result of the event.

For malfunction reports that do not involve a patient, select code 4582 (No Clinical Signs, Symptoms or Conditions).

Health Effects - Health Impact

Select the lowest level, most detailed code or codes that describe what happened to the patient as a result of the event.

For malfunction reports that do not involve a patient, select code 2645 (No Patient Involvement).

For section F10 to be complete, reporters must select at least one code of each type.

Manufacturers (H6)

Manufacturers are required to complete section H of the 3500A form, which includes adverse event problem codes in section H6. H6 prompts the reporter to specify at least one code of each type:

Code Recommendations
Medical Device Problem

Select the lowest level, most detailed code or codes that most accurately describe the device failures or problems observed during the event.

Note: Code 3189 (No Apparent Adverse Event) is for FDA use only, because this code would indicate that the event is by definition not a reportable adverse event.

Medical Device Component

Select the lowest level, most detailed code or codes that most accurately describe the device components that were involved in the failure or problem observed.

If the failure or problem cannot be linked to a specific part, component, or subassembly, select code 4755 (Part/Component/Sub-assembly Term not Applicable).

Cause Investigation - Type of Investigation

Select the lowest level, most detailed code or codes that most accurately describe what was investigated and what kind of investigation was conducted to specify the root cause of the adverse event.

If the investigation is in progress at the time of reporting, it may be appropriate to select code 4118 (Type of Investigation Not Yet Determined). If chosen, submit a follow-up MDR with a different selection after the investigation is complete.

Cause Investigation - Investigation Findings

Select the lowest level, most detailed code or codes that most accurately describe the specific findings in the investigation that are the keys to identify the root cause of the event.

If the investigation is in progress at the time of reporting, it may be appropriate to select code 3233 (Results Pending Completion of Investigation). If chosen, submit a follow-up MDR with a different selection after the investigation is complete.

Cause Investigation - Investigation Conclusion

Select the lowest level, most detailed code or codes that most accurately describe the specific findings in the investigation that are the keys to identify the root cause of the event.

If the investigation is in progress at the time of reporting, it may be appropriate to select code 11 (Conclusion Not Yet Available)). If chosen, submit a follow-up MDR with a different selection after the investigation is complete.

Health Effect – Clinical Signs and Symptoms or Conditions Select the lowest level, most detailed code or codes that describe what happened to the patient as a result of the event. For malfunction reports that do not involve a patient, select code 4582 (No Clinical Signs, Symptoms or Conditions).
Health Effects - Health Impact Select the lowest level, most detailed code or codes that describe what happened to the patient as a result of the event. For malfunction reports that do not involve a patient, select code 2645 (No Patient Involvement).

For section H6 to be complete, reporters must select at least one of each of these seven code types.

Submission Methods

The process of selecting and entering the adverse event codes in an MDR depend upon the submission method used by the reporter. Although two reporters may be the same type of entity (for example, both manufacturers), the process of reporting differs depending on the submission method. This section outlines the process of entering adverse event codes for each possible submission method.

Paper

The eMDR Rule mandatesthat manufacturers and importers (or distributors) submit their MDRs electronically via eMDR. User facilities are still able to submit 3500A paper reports to CDRH.

When filling out section F10, paper reporters should refer to the hierarchy files for Medical Device Problem, Medical Device Component, Health Effects - Clinical Signs and Symptoms or Conditions, and Health Effects - Health Impact, which are available on the Coding Resources page. Reporters should browse each hierarchy and choose the most appropriate code or codes before writing them into the corresponding boxes on the form. When entering the codes, reporters should write only the two to four digit FDA code number in each box.

The 3500A form has space for one of each code type in section F10. If reporters would like to provide more than one code, they may record additional codes by writing “F10:” followed by the additional codes in the H10 block.

eSubmitter

Electronic reporters using eSubmitter to generate MDRs will be prompted to enter adverse event codes once they reach the appropriate section in the 3500A wizard. For each code type, reporters should follow these steps:

  1. Click the + button below the name of the code type. A dialog will appear.
  2. If you know the FDA code number for the code that you wish to use, enter it in the code box at the top left. Then skip to step 4 below.
  3. If you do not know an exact FDA code number, enter a descriptive term, such as the IMDRF term, in the code name box at the top right.
  4. In the area below the code and code number boxes, a section of the hierarchy will be displayed. The hierarchy will contain one or more codes that match the number or term that was entered, as well as their related codes. Highlight one of these codes and click the Select button at the bottom left to add the code to the list of currently selected codes.
  5. If you would like to add more codes of this type, repeat the process from steps 2 through 4.
  6. When you are finished adding codes, click the OK button at the bottom right to return to the main eSubmitter screen.

Once finished entering adverse event codes for all required code types, reporters may continue to the next section in the eSubmitter 3500A wizard.

AS2 XML

Electronic reporters using the ESG AS2 gateway to submit to eMDR must maintain a custom software solution for reporting. A firm's reporting system must be able to generate submission XML files that adhere to the HL7 ICSR schema. For detailed information on how to create the XML submission file for eMDR, as well as where and how to include the appropriate adverse event codes, download the eMDR Implementation Package.

AS2 reporters should note that their HL7 XML custom software may use FDA, NCIt, or IMDRF codes to specify the adverse event problem codes in an electronic MDR.

 
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