Study finds medical device adverse-event summaries often incomplete and late

A study published in The BMJ found that medical device adverse-event summary reports submitted to the FDA are often incomplete, inaccurate or late. Researchers analyzed 6,308 summary reports submitted to the FDA’s MAUDE database from July 2019 to June 2025. The reports contained 159,503 adverse events, mostly involving high-risk devices.

The researchers found that 57% of reports identified no device or use problem, 38% reported insufficient information and 55% exceeded the FDA’s 30-day reporting deadline. They also found that 11% were incorrectly identified as nonsummary reports and 7% incorrectly listed one event in the number-of-events field. The researchers called for immediate improvements. They noted limitations in passive adverse-event reporting and a lack of publicly available information on the requirements for summary-reporting exemptions.