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 reportsMalfunction 12Injury 2
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2020-11 | 0 | 4 |
| 2020-12 | 0 | 10 |
| 2021-01 | 0 | 10.5 |
| 2021-02 | 0 | 6 |
| 2021-03 | 0 | 7 |
| 2021-04 | 0 | 97 |
| 2021-05 | 1 | 2.33 |
| 2021-06 | 0 | 2 |
| 2021-07 | 0 | 5 |
| 2021-08 | 1 | 6.25 |
| 2021-09 | 2 | 13.6 |
| 2021-10 | 0 | 14.67 |
| 2021-11 | 0 | 14.25 |
| 2021-12 | 1 | 40.86 |
| 2022-01 | 3 | 160.6 |
| 2022-02 | 3 | 262.88 |
| 2022-03 | 1 | 247.75 |
| 2022-04 | 0 | 236.6 |
| 2022-05 | 1 | 153 |
| 2022-06 | 0 | 266.25 |
| 2022-07 | 0 | 74.5 |
| 2022-08 | 0 | 174.67 |
| 2022-09 | 0 | 271.33 |
| 2022-10 | 0 | 220 |
| 2022-11 | 0 | 102 |
| 2022-12 | 0 | 183.5 |
| 2023-01 | 0 | 93.2 |
| 2023-02 | 0 | 405 |
| 2023-03 | 0 | 185.67 |
| 2023-04 | 0 | 98.33 |
| 2023-05 | 0 | 239 |
| 2023-06 | 0 | 29 |
| 2023-07 | 0 | 54 |
| 2023-08 | 0 | 22.25 |
| 2023-09 | 0 | 23 |
| 2023-10 | 0 | 7.75 |
| 2023-11 | 0 | 15 |
| 2023-12 | 0 | 6.67 |
| 2024-01 | 1 | 11.8 |
| 2024-02 | 0 | 5.75 |
| 2024-03 | 0 | 8.67 |
| 2024-04 | 0 | 4.67 |
| 2024-05 | 0 | 3 |
| 2024-06 | 0 | 4 |
| 2024-07 | 0 | 3.67 |
| 2024-08 | 0 | 10.5 |
| 2024-09 | 0 | 17 |
| 2024-10 | 0 | 9.8 |
| 2024-11 | 0 | 8.2 |
| 2024-12 | 0 | 2.33 |
| 2025-01 | 0 | 18.33 |
| 2025-02 | 0 | 23 |
| 2025-03 | 0 | 10 |
| 2025-05 | 0 | 17 |
| 2025-06 | 0 | 1 |
| 2025-07 | 0 | 1 |
| 2025-08 | 0 | 28 |
| 2025-09 | 0 | 11 |
| 2025-12 | 0 | 2 |
| 2026-04 | 0 | 1 |
| 2026-05 | 0 | 4 |
Failure-mode summaryAI-generated
14 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2024-01-26 | 1221359-2024-00114 | Malfunction | Available | exact di |
| 2022-05-18 | 1221359-2022-02403 | Malfunction | Available | exact di |
| 2022-03-22 | 1221359-2022-01498 | Malfunction | Available | exact di |
| 2022-02-16 | 1221359-2022-00777 | Injury | Available | exact di |
| 2022-02-07 | 1221359-2022-00797 | Malfunction | Available | exact di |
| 2022-02-04 | 1221359-2022-00651 | Malfunction | Available | exact di |
| 2022-01-23 | 1221359-2022-00503 | Malfunction | Available | exact di |
| 2022-01-22 | 1221359-2022-00485 | Malfunction | Available | exact di |
| 2022-01-19 | 1221359-2022-00318 | Malfunction | Available | exact di |
| 2021-12-28 | 1221359-2020-03873 | Injury | Available | exact di |
| 2021-09-09 | 1221359-2021-02621 | Malfunction | Available | exact di |
| 2021-09-07 | 1221359-2021-02578 | Malfunction | Available | exact di |
| 2021-08-24 | 1221359-2021-02374 | Malfunction | Available | exact di |
| 2021-05-28 | 1221359-2021-01580 | Malfunction | Available | exact di |
Regulatory clearances
None linked.
Manufacturer compliance record
None in the loaded window.
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