ArticleBMJ (Clinical research ed.)2025
Late adverse event reporting from medical device manufacturers to the US Food and Drug Administration: cross sectional study.
Article in BMJ (Clinical research ed.), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
What it found
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
12 citing papers in PubMed.
- Adverse-event reporting profiles of the Intuitive SureForm robotic stapling system in the FDA MAUDE database differ by product code: a comparison of GDW- and NAY-coded reports.Journal of robotic surgery · 2026Article
- Left Atrial Appendage Occlusion Device-Associated Infective Endocarditis: Analysis of the FDA-MAUDE Database.Journal of the Society for Cardiovascular Angiography & Interventions · 2026Article
- Adverse events and device malfunctions in robotic thyroidectomy: a decade-long analysis of the MAUDE database.Journal of robotic surgery · 2026Article
- Maxillary sinus-related adverse event reports associated with endosseous dental implants in the FDA MAUDE database: a retrospective text-mining analysis.BMC oral health · 2026Article
- Two decades of growth and trends in the FDA authorization of digital medical devices.NPJ digital medicine · 2026Article
- Device malfunctions and patient harm in robotic-assisted prostatectomy: a 17-year review of the FDA MAUDE database.Journal of robotic surgery · 2026Article
- Medical Device Regulation - Who Does the FDA Serve?The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics · 2026Review
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- From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review".International journal of health policy and management · 2025Article
- Challenges and dynamics in reporting medical device incidents: a qualitative study.Frontiers in health services · 2025Article
- Safeguarding AI-driven digital health - An adaptation of the Swiss cheese model for safety.Digital healthArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo describe the extent of late adverse event reporting by manufacturers to the US Food and Drug Administration's (FDA) Manufacturer And User Facility Device Experience (MAUDE) database as well as the distribution of late reporting among manufacturers and associations with device characteristics.
designCross sectional study.
settingThe FDA MAUDE database, a central postmarket safety surveillance tool for US medical devices, from 1 September 2019 to 31 December 2022.
participantsMedical device manufacturers that submitted initial adverse event reports to the FDA between 1 September 2019 and 31 December 2022.
main outcome measuresTime in days between date manufacturer was notified of event and date of FDA receipt of adverse event reports, proportion of reports reported late (after the required 30 day window as required by FDA regulation), and distribution of late reporting among manufacturers and medical devices.
results13 587 reports were of deaths, 1 552 268 of injuries, and 2 866 693 of malfunctions received by the FDA from 3028 unique manufacturers and 88 448 unique medical devices in the three and a half year period. Of 4 432 548 included reports, 71.0% (n=3 146 957) of adverse events were reported within 30 days (on time), 4.5% (n=197 606) were reported between 31 and 180 days (late), and 9.1% (n=402 891) were after 180 days (late). 15.5% of reports (n=685 094) had missing or invalid date data provided by the manufacturer. Three manufactures and 13 medical devices were attributed to 54.8% of late reports.
conclusionsNearly a third of manufacturer reports of medical device adverse events were not demonstrably submitted to the FDA within the regulatory deadline, with most late reports being submitted more than six months after manufacturer notification. Most late reports were submitted by a small number of manufacturers. Late adverse event reporting may prevent early detection of patient safety concerns.
Indexed as
Identifiers
What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.