Objectives To evaluate the accuracy and completeness of adverse event summary reports for medical devices and compliance of the reports with the Food and Drug Administration (FDA) requirements. Design Cross sectional study. Setting The FDA manufacturer and user facility device experience (MAUDE) database. Participants All adverse event summary reports filed in MAUDE from July 2019 to June 2025. Main outcome measures Identification of device problem codes, appropriate identification as summary reports in the submission form, concordance between the number of events data field and the report narrative, and compliance with FDA reporting deadlines. Results 6308 summary reports were submitted to MAUDE containing 159 503 adverse events. Use of summary reports increased from 808 to 1757 between 2020 and 2024, a factor of 1.21 per year (P<0.001). Most (91%) adverse events in summary reports were for class 3 high risk devices. Summary reports lacked descriptions of potential device related problems: 57% of reports denoted an “adverse event without identified device or use problem” and 38% of reports selected “insufficient information” in the device problem code data field. Manufacturers incorrectly checked “N” (no) in the summary report (Y/N, reporting yes/no) field for 694 summary reports (11%) and erroneously listed “n=1” under the number of events field for 423 summary reports (7%), causing an undercount of 11 902 adverse events. The majority (55%) of summary reports failed to comply with the FDA reporting deadline of 30 days after the manufacturer became aware of the adverse event. Conclusions Adverse event summary reports in MAUDE are frequently incomplete, inaccurate, and delayed. Improvements are needed to ensure timely identification of device safety signals and uphold FDA transparency standards.
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Zhou et al. (2026) studied this question.
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