A new BMJ-published study has found that nearly 30% of medical device adverse event reports submitted to the FDA’s MAUDE database between September 2019 and December 2022 were either submitted late or contained missing/invalid date data. Researchers reviewed over 4.4 million reports from 3,028 manufacturers and discovered that while 71% met the 30-day submission requirement, the rest were delayed—some by more than six months—or were incomplete.

Alarmingly, just three manufacturers were responsible for over half of the late reports: Becton Dickinson (25.2%), Medtronic (19.5%), and Dentsply (10.1%). Delays were often released in large batches, sometimes coinciding with product recalls.

Lead author Alexander Everhart of Washington University emphasized that such delays risk patient safety and called for policy reforms. The team proposed stronger enforcement, greater transparency, and a shift toward more proactive, data-integrated surveillance to improve the timeliness and accuracy of safety reporting.