Evaluation of the accuracy, completeness, and compliance of current summary reporting of adverse events to the Food and Drug Administration using the manufacturer and user facility device experience (MAUDE) database: cross sectional study.

Adverse event summary reports in the FDA's MAUDE database are frequently incomplete, inaccurate, and delayed. Of 6308 summary reports containing 159,503 adverse events, 57% denoted an adverse event without an identified device or use problem and 38% selected insufficient information as the device problem code; errors in the summary report and number of events fields caused an undercount of 11,902 adverse events, and 55% of reports missed the FDA's 30 day reporting deadline. Use of summary reports rose from 808 in 2020 to 1757 in 2024, with 91% of events involving class 3 high risk devices.