GLOSSARYUSEUCA
Adverse Event Reporting
The reports a manufacturer, and in some regimes an importer, must send a regulator about problems with a device.
Regimes
- Medical Device ReportA report to the FDA from a manufacturer, importer, or device user facility. The report is required when a device may have caused or contributed to a death or serious injury. A malfunction that would likely cause one if it recurred also triggers the report. Part 803 sets the report types and deadlines.
- Serious Incident ReportA manufacturer's report of a serious incident to the competent authorities. The deadline is 15 days after the manufacturer becomes aware of the incident. The deadline shortens to 10 days for a death or an unanticipated serious deterioration in health, and to 2 days for a serious public health threat.
- Incident Reporting (CA)A manufacturer and an importer must each give the Minister a preliminary and a final report on an incident in Canada involving a device sold there. The incident must relate to a device failure or inadequate labeling, and have led to death or a serious deterioration in health, or could if it recurred.