Device Manufacturers Often Delay Reporting Adverse Events
Four major manufacturers account for nearly half of late reports
Healthcare professionals and the device industry share responsibility for timely adverse event reporting
Lapses defeat the purpose of adverse event reporting
A recent study published in the British Medical Journal has spotlighted a troubling trend: many medical device manufacturers are failing to report adverse safety events to the FDA on time, potentially putting patients at risk.
Under current FDA regulations, manufacturers must report serious malfunctions, injuries, or deaths associated with their devices within 30 days. These reports feed into the MAUDE database (Manufacturer and User Facility Device Experience), a critical tool for postmarket surveillance and safety communication.
But from 2019 to 2022, only 71% of reports met that 30-day deadline. Worse, more than 600,000 incidents were reported late — some by as much as six months or more. These delays included:
- 1,004 deaths
- 198,051 injuries
- 401,442 device malfunctions
What the Study Found
Lead author Dr. Alexander Everhart of Washington University in St. Louis noted two major concerns:
- Massive reporting delays: When reports are late, they tend to be very late.
- Batch reporting behavior: Manufacturers often submit large volumes of overdue reports in a single month, suggesting systemic delays in internal review and reporting practices.
The data show that three industry giants and their products – just three companies and 13 devices – were responsible for over half of the late reports. Devices most often associated with delayed reports include:
- Becton Dickinson’s infusion pumps
- Abbott and Dexcom’s glucose monitors
- Medtronic’s insulin pumps
- Biohorizons’ dental implants
Becton Dickinson, one of the companies named, responded by saying the flagged reports stemmed from a retrospective review of service records, not from customer complaints — and they’ve since upgraded their IT and quality systems.
Why Timely Reporting Matters
Unlike pharmaceuticals, many devices receive FDA approval based on limited clinical data. That makes postmarket surveillance essential for detecting safety issues early. Delays in adverse event reporting:
- Undermine the FDA’s ability to respond to emerging risks
- Prevent clinicians and patients from making informed decisions
- May result in avoidable patient harm
This isn’t the first time reporting delays have raised concern. Investigative journalism by outlets like ProPublica and KFF Health News has long warned of the risks when device makers fail to communicate problems swiftly.
Regulatory Oversight Under Pressure
The study also raises concerns about the FDA’s capacity to enforce reporting rules amid federal workforce cuts. In February 2025, the agency’s Center for Devices and Radiological Health lost around 180 employees — including experts in medicine and cybersecurity — as part of sweeping budget cuts.
Although some staff were later reinstated, postmarket surveillance teams may have been disproportionately affected, threatening the FDA’s ability to detect and respond to device-related safety issues in real time.
What Can Be Done?
Dr. Everhart suggests several solutions:
- Revamp the FDA’s reporting system to require manufacturers to disclose when they became aware of adverse events.
- Enforce timely reporting through penalties or legal action.
- Encourage investigative journalism and public transparency on reporting trends and FDA responsiveness.
The bottom line? Delays in reporting aren’t just a regulatory lapse — they’re a patient safety issue. And with shrinking federal resources, the burden may increasingly fall on the public, researchers, and the media to hold the system accountable.
Takeaway for Device Manufacturers
If you manufacture or distribute medical devices in the U.S., this is a wake-up call. Now more than ever, timely and transparent adverse event reporting must be prioritized. Not only is it a regulatory requirement — it is a moral and professional responsibility.
Need help reviewing your postmarket surveillance systems or streamlining your FDA reporting process?
Contact Medical Devices and Pharma (MDP) today for expert support on regulatory compliance, internal audits, and QMSR transition readiness.