Late adverse event reporting from medical device manufacturers to the US Food and Drug Administration: cross sectional study.

Everhart, Karaca-Mandic, Redberg, Ross, Dhruva. Late adverse event reporting from medical device manufacturers to the US Food and Drug Administration: cross sectional study. BMJ (Clinical research ed.). 2025 Mar 12; 388:e081518, DOI: 10.1136/bmj-2024-081518.

Dimensions for VA is a web-based tool available to VA staff that enables detailed searches of published research and research projects.

If you have VA-Intranet access, click here for more information vaww.hsrd.research.va.gov/dimensions/

VA staff not currently on the VA network can access Dimensions by registering for an account using their VA email address.    Search Dimensions for VA for this citation
* Don't have VA-internal network access or a VA email address? Try searching the free-to-the-public version of Dimensions

Search for Abstract from PubMed

---

Abstract:

OBJECTIVE: To 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. DESIGN: Cross sectional study. SETTING: The FDA MAUDE database, a central postmarket safety surveillance tool for US medical devices, from 1 September 2019 to 31 December 2022. PARTICIPANTS: Medical device manufacturers that submitted initial adverse event reports to the FDA between 1 September 2019 and 31 December 2022. MAIN OUTCOME MEASURES: Time 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. RESULTS: 13 587 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. CONCLUSIONS: Nearly 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.