Medical Device Incidents - disclaimers

Caveat

The incidents in this database represent the perspective of those who send us the reports.

Not all incidents are reported, so using these data to estimate risks may not be accurate.

Those who send us reports may be more or less likely to report depending on the issue, the device(s) involved, or factors like media coverage.

These data don’t represent all known safety information concerning the device(s) and should not be used on their own to make decisions about the use of these devices.

The association of a device with any patient harm or outcomes doesn’t mean that the device caused the harm or outcome.

Information related to the identity of people who report a voluntary incident is protected under the Privacy Act.

Definitions

Pending Assessment: Reports have been received, but have not yet undergone review and coding for patient and device codes. Fields will be updated as the assessment is completed.

Not Specified: Patient and device codes are not specified for certain report types, such as recalls and reports submitted on a voluntary basis. Patient and device codes are also not specified in certain situations, such as legacy reports for which final reports were never received.