Medical Device Report Data Files

The U.S. FDA updated the medical device report data files, posting the Patient Problem Codes associated with “legacy Alternative Summary Report (ASR) files” on https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/mdr-data-files?utm_medium=email&utm_source=govdelivery. This update follows the addition of Patient Problem Codes to the public Manufacturer and User Facility Device Experience (MAUDE) database in September 2020 to provide additional information on the nature of adverse events and related devices, when available.

The FDA continues to actively work on making the MAUDE database more user-friendly and increase the transparency in medical device reporting.