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Regulatory presence across jurisdictions

The same device (matched on an identical UDI-DI) is registered in other jurisdictions. EU coverage (EUDAMED) is still phasing in — absence here does not mean a device is not marketed there.

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.

5 linked reportsInjury 5
01112021-08: 1 reports for this device2021-10: 1 reports for this device2021-11: 1 reports for this device2022-01: 1 reports for this device2022-04: 1 reports for this device0810110104
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2021-081—
2021-101—
2021-111—
2022-011—
2022-041—
This device (reports/month)Average device in its product code (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2022-04-273009532798-2022-00108InjuryAvailableexact di
2022-01-123009532798-2021-00254InjuryAvailableexact di
2021-11-153009532798-2021-00172InjuryAvailableexact di
2021-10-223009532798-2021-00160InjuryAvailableexact di
2021-08-053009532798-2021-00112InjuryAvailableexact di
Regulatory clearances

None linked.

Manufacturer compliance record

None in the loaded window.

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