21 CFR 803 contains Medical Device Reporting requirements for significant adverse events, including fatal injuries. The US FDA reporting requirements for medical device deaths and injuries affect medical device manufacturers, importers, and user facilities like hospitals and nursing homes. Our Houston implant injury lawyers mention that there are different levels of reporting requirements depending upon the seriousness of the adverse event:
Deaths: Manufacturers, importers, and user facilities are required to report it to the FDA when they learn that one of their medical devices may have contributed to or caused a fatality. User facilities must also report the death to the manufacturer.
Serious injuries: Manufacturers and importers must report to the FDA when they learn that one of their medical devices has caused or contributed to a serious injury. User facilities need only report the injury to the manufacturer, unless the manufacturer is unknown. Then they report the serious injury to the FDA.
Malfunctions: Manufacturers are required to report it to the FDA when they learn that one of their medical devices has malfunctioned and would likely cause or contribute to a serious injury or fatality if it happened again. Importers are required to report this only to the manufacturer. And our Houston implant injury lawyers point out that user facilities are not required to report this at all, though they may choose to do so voluntarily through the Medwatch program.
The theory behind having importers and user facilities like hospitals report adverse events only to the manufacturer likely rests on an assumption that the manufacturers will dutifully report all these problems to the FDA as required by law. But the Houston implant injury lawyers at Denena Points, PC emphasize that study after study has revealed that medical device-related injuries, malfunctions, and even deaths could be vastly underreported. In fact, a 1986 study by the government’s own General Accounting Office found that less than 1% (one percent) of the medical device problems that happen in hospitals get reported to the FDA, AND that the more serious the problem was with the device, the LESS likely it was to be reported.
Contact us to report a Serious Injury from a Medical Device that has injured You or Your Loved Ones
The concerned Houston implant injury lawyers at Denena Points, PC take these reports very seriously. We want to make sure the FDA learns of significant adverse events and that victims and their families get the help and compensation they deserve after a medical device flaw or malfunction has caused them harm.
Call us at 713-807-9500 or reach us anytime through our online contact form to set up a free initial legal consultation to discuss your case and evaluate your eligibility for proper compensation for the needless harm you’ve suffered. Let our more than 12 years of experience successfully helping injured clients and families in complex personal injury and wrongful death cases guide you in making informed choices after a serious adverse event involving a medical device. You have no obligation to hire an attorney. And we never charge you attorneys’ fees unless we win your case for you.