The US FDA collects adverse event reports for medical devices through the MAUDE database where serious and fatality reports can be viewed by the public. Records reporting fatalities associated with medical devices often say "additional information" requested with no additional information or follow up posted.
- The FDA should aggressively and transparently investigate reports of fatalities and serious adverse events.
- Patients have the right to know the risks of medical devices they may be considering.
- When fatalities are reported, the FDA should aggressively investigate to determine if the device has contributed.
- Medical devices showing a pattern of fatality should be suspended until their safety can be verified and guaranteed.
Protect the American public!