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.
1 linked reportInjury 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-02 | 0 | 1 |
| 2019-05 | 0 | 1 |
| 2019-09 | 0 | 1 |
| 2019-10 | 0 | 2 |
| 2019-11 | 0 | 1 |
| 2020-03 | 0 | 1 |
| 2020-05 | 0 | 2 |
| 2020-06 | 0 | 1 |
| 2020-09 | 0 | 1 |
| 2020-12 | 0 | 6 |
| 2021-02 | 0 | 2 |
| 2021-05 | 0 | 1.5 |
| 2021-07 | 0 | 2 |
| 2021-08 | 0 | 1 |
| 2021-09 | 0 | 1 |
| 2021-10 | 0 | 1 |
| 2022-05 | 0 | 1 |
| 2022-07 | 0 | 1.5 |
| 2022-08 | 0 | 2 |
| 2022-10 | 0 | 2 |
| 2022-12 | 0 | 1 |
| 2023-01 | 1 | 1 |
| 2023-03 | 0 | 3 |
| 2023-04 | 0 | 2 |
| 2023-06 | 0 | 2 |
| 2023-10 | 0 | 2 |
| 2023-11 | 0 | 1 |
| 2023-12 | 0 | 1 |
| 2024-03 | 0 | 1 |
| 2024-04 | 0 | 1 |
| 2024-06 | 0 | 1.67 |
| 2024-07 | 0 | 1.67 |
| 2024-08 | 0 | 1 |
| 2024-10 | 0 | 1 |
| 2024-11 | 0 | 1 |
| 2024-12 | 0 | 1.67 |
| 2025-01 | 0 | 2.14 |
| 2025-03 | 0 | 1.5 |
| 2025-07 | 0 | 1 |
| 2025-09 | 0 | 1.25 |
| 2025-12 | 0 | 1.5 |
| 2026-01 | 0 | 1 |
| 2026-02 | 0 | 1 |
| 2026-03 | 0 | 1 |
| 2026-04 | 0 | 1.33 |
| 2026-05 | 0 | 1.5 |
| 2026-06 | 0 | 1.5 |
Failure-mode summaryAI-generated
1 linked report narrative available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2023-01-03 | 1000432246-2023-00003 | Injury | Available | exact di |
Regulatory clearances
Predicate lineage
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2017-02-16 | VAI | Voluntary action indicated | Medicrea International | 5 |
| 2013-06-20 | VAI | Voluntary action indicated | Medicrea International | 0 |
| 2013-06-19 | VAI | Voluntary action indicated | Medicrea International | 5 |
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