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# One-third of MAUDE Reports Submitted Late: Study
- URL: https://www.fdaweb.com/one-third-of-maude-reports-submitted-late-study/
- Published: 2025-03-13T12:00:00.000Z
- Updated: 2026-09-14T14:55:16.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5158819

Nearly one-third of medical device adverse event reports submitted to FDA’s Manufacturer and User Facility Device Experience (MAUDE) database arrived later than the 30 days allowed by agency regulations, according to an analysis by researchers from several academic medical centers. “Late reporting to the MAUDE database could preclude identification of patient safety concerns in a timely manner,” the researchers write in their open-source *BMJ* [report](https://www.bmj.com/content/388/bmj-2024-081518?ref=fdaweb.com).

The researchers analyzed over four million reports submitted to MAUDE between 9/1/2019 and 12/31/2022\. They found that over one million reports were submitted late, and over 400,000 of them came in more than six months after manufacturer notification of the adverse event. “Many of the devices with large numbers of late reports were critical to patient care,” the study says, “including devices like infusion pumps used in hospitals and continuous glucose monitors used by patients in ambulatory settings.”

The authors say that late death reports are potentially the most serious omission from MAUDE and were concentrated in problematic areas. Breakthrough device deaths were reported late more often than non-breakthrough device deaths. Also, Class 2 and 3 recalled devices had a lower overall late reporting rate but higher late reporting rates for deaths and injuries compared with devices with no recalls.

The article includes policy and enforcement suggestions for FDA to increase on-time reporting.