Skip to content
Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

2 linked reportsInjury 2
4812162019-02: 0 reports for this device; peer average 1/device2019-08: 0 reports for this device; peer average 1/device2020-02: 1 reports for this device; peer average 1/device2020-05: 0 reports for this device; peer average 1/device2021-12: 1 reports for this device; peer average 1/device2023-11: 0 reports for this device; peer average 16/device2023-12: 0 reports for this device; peer average 4/device02080205121112
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0201
2019-0801
2020-0211
2020-0501
2021-1211
2023-11016
2023-1204
This device (reports/month)Average device in IKX (reports/device/month)
Failure-mode summaryAI-generated

2 linked report narratives available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2021-12-281417592-2021-00231InjuryAvailableexact di
2020-02-051417592-2020-00005InjuryAvailableexact di
Regulatory clearances

None linked.

Manufacturer compliance record

None in the loaded window.

Similar devices
Select up to two to place side-by-side with this device.