BMJ: FDA MAUDE bulk summary reports of device adverse events often incomplete, inaccurate or late

A cross-sectional study published in The BMJ (2026;395:e100812) analysed how medical-device makers use bulk summary adverse-event reports in the US FDA’s MAUDE database — and found frequent gaps in completeness, accuracy and timeliness.

What researchers examined

US rules generally require manufacturers to report malfunctions and adverse events to MAUDE within 30 days. After the FDA ended the older Alternative Summary Reporting program in 2019, similar summary reporting exemptions remained. Investigators reviewed all summary reports from July 2019 to June 2025: 6,308 reports covering 159,503 events, mostly involving high-risk devices.

Key findings

Per the BMJ/BMJ Group coverage: 57% identified no device or use problem; 38% selected insufficient information; 11% were incorrectly labelled as non-summary reports; 7% incorrectly listed one event in the event-count field (undercounting 11,902 events in related reporting); and 55% exceeded the 30-day deadline. Summary-report volume and events contained more than doubled between 2020 and 2024, adding urgency, the authors argue.

Study type and limitations

This is a retrospective cross-sectional analysis of publicly posted MAUDE summary submissions — passive postmarket surveillance, not a clinical trial of any device’s safety. Authors note limited public detail on exemption requirements. A linked editorial urged accurate timely reporting and combining spontaneous reports with registries and linked health data. The FDA is also transitioning toward a new Adverse Event Monitoring System (AEMS), the editorial notes. Findings describe reporting quality, not the absolute risk of any named product. This is not personal medical advice; device concerns belong with clinicians and regulators. DOI: 10.1136/bmj-2026-100812