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.
- United States0072499518416200724995184162
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.
3 linked reportsMalfunction 3
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2022-03 | 1 | — |
| 2024-10 | 1 | — |
| 2025-04 | 1 | — |
Failure-mode summaryAI-generated
3 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-04-03 | 1528319-2025-00026 | Malfunction | Available | exact di |
| 2024-10-17 | 1528319-2024-00089 | Malfunction | Available | exact di |
| 2022-03-25 | 1528319-2022-00015 | Malfunction | Available | exact di |
Regulatory clearances
None linked.
Manufacturer compliance record
None in the loaded window.
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