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.
19 linked reportsMalfunction 19
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2021-05 | 0 | 3 |
| 2021-06 | 0 | 4 |
| 2021-07 | 0 | 29 |
| 2021-08 | 0 | 48 |
| 2021-09 | 0 | 65 |
| 2021-10 | 0 | 19 |
| 2021-11 | 0 | 24 |
| 2021-12 | 0 | 44 |
| 2022-01 | 0 | 30 |
| 2022-02 | 0 | 15.33 |
| 2022-03 | 0 | 11.5 |
| 2022-04 | 0 | 19 |
| 2022-05 | 0 | 20.5 |
| 2022-06 | 0 | 15.25 |
| 2022-07 | 0 | 14 |
| 2022-08 | 0 | 13 |
| 2022-09 | 0 | 22 |
| 2022-10 | 0 | 44 |
| 2022-11 | 0 | 39.33 |
| 2022-12 | 0 | 30 |
| 2023-01 | 0 | 54.5 |
| 2023-02 | 0 | 26 |
| 2023-03 | 0 | 34.5 |
| 2023-04 | 0 | 45 |
| 2023-05 | 0 | 35 |
| 2023-06 | 0 | 18 |
| 2023-07 | 0 | 17 |
| 2023-08 | 0 | 20 |
| 2023-09 | 0 | 14.67 |
| 2023-10 | 0 | 75 |
| 2023-11 | 0 | 58 |
| 2023-12 | 1 | 17.67 |
| 2024-01 | 2 | 32 |
| 2024-02 | 0 | 31.5 |
| 2024-03 | 0 | 14 |
| 2024-04 | 0 | 6 |
| 2024-05 | 0 | 4 |
| 2024-06 | 0 | 1.5 |
| 2024-07 | 0 | 6 |
| 2024-08 | 5 | 7.75 |
| 2024-09 | 0 | 4 |
| 2024-10 | 4 | 5 |
| 2024-11 | 0 | 2.75 |
| 2024-12 | 0 | 5.5 |
| 2025-01 | 7 | 6.75 |
| 2025-02 | 0 | 1.5 |
| 2025-03 | 0 | 4.5 |
| 2025-04 | 0 | 3 |
| 2025-05 | 0 | 1 |
| 2025-06 | 0 | 3 |
| 2025-07 | 0 | 1 |
| 2025-08 | 0 | 2 |
| 2025-09 | 0 | 1.5 |
| 2025-10 | 0 | 5 |
| 2025-11 | 0 | 5.5 |
| 2025-12 | 0 | 4 |
| 2026-01 | 0 | 2 |
| 2026-02 | 0 | 4 |
| 2026-03 | 0 | 3 |
| 2026-04 | 0 | 2 |
| 2026-05 | 0 | 2 |
Failure-mode summaryAI-generated
19 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-01-14 | 1221359-2025-00008 | Malfunction | Available | exact di |
| 2025-01-14 | 1221359-2025-00010 | Malfunction | Available | exact di |
| 2025-01-14 | 1221359-2025-00011 | Malfunction | Available | exact di |
| 2025-01-14 | 1221359-2025-00013 | Malfunction | Available | exact di |
| 2025-01-14 | 1221359-2025-00009 | Malfunction | Available | exact di |
| 2025-01-14 | 1221359-2025-00007 | Malfunction | Available | exact di |
| 2025-01-14 | 1221359-2025-00012 | Malfunction | Available | exact di |
| 2024-10-07 | 1221359-2024-00635 | Malfunction | Available | exact di |
| 2024-10-07 | 1221359-2024-00634 | Malfunction | Available | exact di |
| 2024-10-07 | 1221359-2024-00636 | Malfunction | Available | exact di |
| 2024-10-07 | 1221359-2024-00637 | Malfunction | Available | exact di |
| 2024-08-22 | 1221359-2024-00560 | Malfunction | Available | exact di |
| 2024-08-20 | 1221359-2024-00563 | Malfunction | Available | exact di |
| 2024-08-20 | 1221359-2024-00561 | Malfunction | Available | exact di |
| 2024-08-20 | 1221359-2024-00559 | Malfunction | Available | exact di |
Showing 1–15 of 19
Regulatory clearances
None linked.
Manufacturer compliance record
None in the loaded window.
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