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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
11222021-02: 1 reports for this device2021-03: 2 reports for this device2021-12: 2 reports for this device2022-01: 1 reports for this device2022-02: 1 reports for this device2022-03: 1 reports for this device2022-06: 1 reports for this device2022-08: 1 reports for this device2023-04: 1 reports for this device2024-08: 1 reports for this device2024-09: 1 reports for this device2026-04: 1 reports for this device020312010203060804080904
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2021-021—
2021-032—
2021-122—
2022-011—
2022-021—
2022-031—
2022-061—
2022-081—
2023-041—
2024-081—
2024-091—
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
2026-04-273009532798-2026-00015InjuryAvailableexact di
2024-09-063014128390-2024-00045InjuryAvailableexact di
2024-08-233014128390-2024-00042InjuryAvailableexact di
2023-04-053009532798-2023-00014InjuryAvailableexact di
2022-08-043009532798-2022-00118InjuryAvailableexact di
2022-06-013009532798-2022-00111InjuryAvailableexact di
2022-03-023009532798-2022-00064InjuryAvailableexact di
2022-02-073009532798-2022-00013InjuryAvailableexact di
2022-01-053009532798-2021-00228InjuryAvailableexact di
2021-12-233009532798-2021-00220InjuryAvailableexact di
2021-12-153009532798-2021-00208InjuryAvailableexact di
2021-03-163009532798-2021-00030InjuryAvailableexact di
2021-03-023009532798-2021-00026InjuryAvailableexact di
2021-02-243009532798-2021-00022InjuryAvailableexact di
Regulatory clearances

None linked.

Manufacturer compliance record

None in the loaded window.

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