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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.

14 linked reportsInjury 14
12232021-02: 2 reports for this device2021-10: 1 reports for this device2021-12: 2 reports for this device2022-03: 3 reports for this device2022-04: 1 reports for this device2022-06: 1 reports for this device2023-02: 1 reports for this device2024-01: 1 reports for this device2025-06: 1 reports for this device2026-04: 1 reports for this device02101203040602010604
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2021-022—
2021-101—
2021-122—
2022-033—
2022-041—
2022-061—
2023-021—
2024-011—
2025-061—
2026-041—
This device (reports/month)Average device in its product code (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2026-04-293009532798-2026-00016InjuryAvailableexact di
2025-06-173009532798-2025-00040InjuryAvailableexact di
2024-01-093009532798-2023-00141InjuryAvailableexact di
2023-02-093009532798-2023-00007InjuryAvailableexact di
2022-06-013009532798-2022-00110InjuryAvailableexact di
2022-04-043009532798-2022-00097InjuryAvailableexact di
2022-03-253009532798-2022-00009InjuryAvailableexact di
2022-03-033009532798-2022-00038InjuryAvailableexact di
2022-03-023009532798-2022-00067InjuryAvailableexact di
2021-12-273009532798-2021-00188InjuryAvailableexact di
2021-12-233009532798-2021-00203InjuryAvailableexact di
2021-10-223009532798-2021-00158InjuryAvailableexact di
2021-02-193009532798-2021-00018InjuryAvailableexact di
2021-02-183009532798-2021-00017InjuryAvailableexact di
Regulatory clearances

None linked.

Manufacturer compliance record

None in the loaded window.

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