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.
2 linked reportsInjury 2
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.85 |
| 2019-02 | 0 | 2.49 |
| 2019-03 | 0 | 2.76 |
| 2019-04 | 0 | 2.63 |
| 2019-05 | 0 | 2.09 |
| 2019-06 | 0 | 1.79 |
| 2019-07 | 0 | 1.83 |
| 2019-08 | 0 | 2.07 |
| 2019-09 | 0 | 2.26 |
| 2019-10 | 0 | 2.43 |
| 2019-11 | 0 | 2.07 |
| 2019-12 | 0 | 2.37 |
| 2020-01 | 0 | 2.7 |
| 2020-02 | 1 | 2.42 |
| 2020-03 | 0 | 3.05 |
| 2020-04 | 0 | 2.22 |
| 2020-05 | 0 | 2.22 |
| 2020-06 | 0 | 1.98 |
| 2020-07 | 0 | 2.41 |
| 2020-08 | 0 | 1.95 |
| 2020-09 | 0 | 2.42 |
| 2020-10 | 0 | 2.44 |
| 2020-11 | 0 | 2.23 |
| 2020-12 | 0 | 2.22 |
| 2021-01 | 0 | 2.34 |
| 2021-02 | 0 | 1.98 |
| 2021-03 | 0 | 1.98 |
| 2021-04 | 0 | 1.99 |
| 2021-05 | 0 | 1.97 |
| 2021-06 | 0 | 2.38 |
| 2021-07 | 0 | 2.28 |
| 2021-08 | 0 | 2.18 |
| 2021-09 | 0 | 2.34 |
| 2021-10 | 0 | 2.13 |
| 2021-11 | 0 | 2.08 |
| 2021-12 | 0 | 2.26 |
| 2022-01 | 0 | 2.03 |
| 2022-02 | 0 | 2.14 |
| 2022-03 | 0 | 2.06 |
| 2022-04 | 0 | 2.12 |
| 2022-05 | 0 | 2.08 |
| 2022-06 | 0 | 2.16 |
| 2022-07 | 0 | 2.01 |
| 2022-08 | 0 | 2.1 |
| 2022-09 | 0 | 2.1 |
| 2022-10 | 0 | 2.07 |
| 2022-11 | 0 | 2.19 |
| 2022-12 | 0 | 2.12 |
| 2023-01 | 0 | 2.17 |
| 2023-02 | 0 | 2.03 |
| 2023-03 | 0 | 2.24 |
| 2023-04 | 0 | 2.15 |
| 2023-05 | 0 | 2.12 |
| 2023-06 | 0 | 2.2 |
| 2023-07 | 0 | 2.06 |
| 2023-08 | 0 | 1.94 |
| 2023-09 | 0 | 1.95 |
| 2023-10 | 0 | 1.61 |
| 2023-11 | 0 | 1.58 |
| 2023-12 | 0 | 1.66 |
| 2024-01 | 0 | 1.7 |
| 2024-02 | 0 | 1.99 |
| 2024-03 | 0 | 1.91 |
| 2024-04 | 0 | 1.7 |
| 2024-05 | 0 | 2.03 |
| 2024-06 | 0 | 1.85 |
| 2024-07 | 0 | 1.69 |
| 2024-08 | 0 | 1.83 |
| 2024-09 | 0 | 1.97 |
| 2024-10 | 0 | 1.76 |
| 2024-11 | 0 | 1.69 |
| 2024-12 | 0 | 1.54 |
| 2025-01 | 0 | 1.85 |
| 2025-02 | 0 | 1.51 |
| 2025-03 | 0 | 1.77 |
| 2025-04 | 0 | 1.79 |
| 2025-05 | 0 | 1.67 |
| 2025-06 | 0 | 1.81 |
| 2025-07 | 0 | 1.8 |
| 2025-08 | 0 | 1.67 |
| 2025-09 | 1 | 1.72 |
| 2025-10 | 0 | 1.7 |
| 2025-11 | 0 | 1.8 |
| 2025-12 | 0 | 1.88 |
| 2026-01 | 0 | 1.98 |
| 2026-02 | 0 | 1.63 |
| 2026-03 | 0 | 1.96 |
| 2026-04 | 0 | 1.85 |
| 2026-05 | 0 | 1.7 |
| 2026-06 | 0 | 1.7 |
Failure-mode summaryAI-generated
2 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-09-09 | 0001825034-2025-02852 | Injury | Available | exact di |
| 2020-02-04 | 0001825034-2020-00481 | Injury | Available | exact di |
Regulatory clearances
Predicate lineage
K043547
Cited as predicate by: K101475
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
None in the loaded window.
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