Medical Device Adverse Event Reports Often Incomplete, Inaccurate

THURSDAY, Oct. 22, 2026 (HealthDay News) -- Medical device adverse event reports are frequently incomplete, inaccurate, and delayed, according to a study published online Oct. 14 in The BMJ.Alyssa Zhou, from the University of California, San Francisco, and colleagues examined the accuracy and completeness of adverse event summary reports for medical devices and compliance with U.S. Food and Drug Administration requirements. All adverse events summary reports filed in the FDA Manufacturer and User Facility Device Experience (MAUDE) database from July 2019 through June 2025 were included.The researchers found that 6,308 summary reports containing 159,503 adverse events were submitted to MAUDE. From 2020 to 2024, there was an increase in the use of summary reports from 808 to 1,757 (factor of 1.21 per year). Overall, 91 percent of the adverse events in summary reports were for class 3 high-risk devices. Descriptions of potential device-related problems were lacking in summary reports: 57 percent of reports denoted an adverse event without an identified device or use problem, and 38 percent selected "insufficient information" in the device problem code data field. For 694 summary reports, manufacturers incorrectly checked "no" in the summary report field and erroneously listed "1" under the number of events for 423 summary reports, resulting in an undercount of 11,902 adverse events. Fifty-five percent of summary reports failed to comply with the 30-day FDA reporting deadline after the manufacturer became aware of the adverse event."Transparency builds trust, evidence improves safety, and both are essential to effective postmarket surveillance and safer medical devices," editorial author Koji Todaka, of Kyushu University Hospital in Japan, said in a statement.Abstract/Full TextEditorial.Sign up for our weekly HealthDay newsletter

Medical Device Adverse Event Reports Often Incomplete, Inaccurate

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