Patient problem codes associated with Alternative Summary Report (ASR) files are now available on the FDA.gov website.

If your email program has trouble displaying this email, view as a webpage. Update to Medical Device Report Data Files Today, the U.S. Food and Drug Administration (FDA) posted the Patient Problem Codes associated with legacy Alternative Summary Report (ASR) files on FDA.gov. 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. Read More Questions? If you have questions, contact the Division of Industry and Consumer Education.

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