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 reportsInjury 3
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2022-04 | 1 | 1 |
| 2022-06 | 0 | 3 |
| 2022-07 | 0 | 1.67 |
| 2022-08 | 0 | 2 |
| 2022-09 | 0 | 12 |
| 2022-10 | 0 | 10 |
| 2022-12 | 0 | 2 |
| 2023-01 | 0 | 4 |
| 2023-02 | 0 | 2 |
| 2023-03 | 0 | 2 |
| 2023-04 | 0 | 5 |
| 2023-05 | 0 | 4 |
| 2023-06 | 0 | 2 |
| 2023-07 | 0 | 2 |
| 2023-08 | 0 | 2.2 |
| 2023-09 | 0 | 4 |
| 2023-10 | 0 | 2 |
| 2023-11 | 0 | 1 |
| 2023-12 | 0 | 1 |
| 2024-01 | 0 | 2 |
| 2024-03 | 0 | 2.67 |
| 2024-04 | 0 | 2 |
| 2024-05 | 0 | 2 |
| 2024-06 | 0 | 4 |
| 2024-09 | 0 | 4 |
| 2024-11 | 0 | 1.83 |
| 2024-12 | 0 | 1 |
| 2025-01 | 0 | 2 |
| 2025-02 | 0 | 1.75 |
| 2025-03 | 0 | 2 |
| 2025-04 | 0 | 2.33 |
| 2025-05 | 0 | 2.71 |
| 2025-06 | 0 | 1.86 |
| 2025-07 | 0 | 4 |
| 2025-08 | 0 | 2.4 |
| 2025-09 | 0 | 2 |
| 2025-11 | 0 | 2 |
| 2025-12 | 0 | 2 |
| 2026-01 | 0 | 1.67 |
| 2026-02 | 0 | 2.29 |
| 2026-03 | 0 | 3 |
| 2026-04 | 0 | 3 |
| 2026-05 | 2 | 2 |
| 2026-06 | 0 | 2 |
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 |
|---|---|---|---|---|
| 2026-05-28 | MW5188675 | Injury | Available | model number |
| 2022-04-15 | MW5109070 | Injury | Available | procode brand trgm |
Showing the most recent 2 of 3 linked reports.
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2023-06-21 | VAI | Voluntary action indicated | Mag & More Gmbh | 4 |
| 2023-06-21 | VAI | Voluntary action indicated | Mag & More Gmbh | 4 |
| 2019-05-31 | NAI | No action indicated | Mag & More Gmbh | 0 |
| 2019-05-31 | NAI | No action indicated | Mag & More Gmbh | 0 |
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