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.
60 linked reportsMalfunction 60
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 1 | 1.4 |
| 2019-02 | 2 | 1.29 |
| 2019-03 | 0 | 1.33 |
| 2019-04 | 1 | 2 |
| 2019-06 | 0 | 1.33 |
| 2019-07 | 0 | 1.25 |
| 2019-09 | 0 | 1 |
| 2019-10 | 0 | 1 |
| 2019-11 | 0 | 1 |
| 2019-12 | 0 | 2.5 |
| 2020-01 | 1 | 1 |
| 2020-03 | 0 | 1.67 |
| 2020-05 | 0 | 1 |
| 2020-07 | 0 | 1 |
| 2020-09 | 0 | 1 |
| 2020-10 | 1 | 1 |
| 2021-01 | 0 | 1 |
| 2021-03 | 0 | 1 |
| 2021-05 | 0 | 1 |
| 2021-06 | 0 | 2.33 |
| 2021-07 | 0 | 1.4 |
| 2021-08 | 0 | 1 |
| 2021-09 | 0 | 1 |
| 2021-10 | 0 | 1 |
| 2021-11 | 0 | 1 |
| 2022-03 | 0 | 1 |
| 2022-04 | 0 | 1.2 |
| 2022-05 | 0 | 2.5 |
| 2022-07 | 0 | 1 |
| 2022-08 | 0 | 1 |
| 2022-09 | 2 | 2 |
| 2022-10 | 0 | 2.67 |
| 2022-11 | 0 | 1 |
| 2023-01 | 0 | 1 |
| 2023-03 | 2 | 1.67 |
| 2023-04 | 0 | 1.5 |
| 2023-05 | 0 | 1 |
| 2023-06 | 0 | 1.5 |
| 2023-07 | 0 | 2 |
| 2023-09 | 0 | 1 |
| 2023-10 | 0 | 2 |
| 2023-11 | 0 | 1 |
| 2023-12 | 0 | 1 |
| 2024-02 | 0 | 1.5 |
| 2024-03 | 0 | 1 |
| 2024-04 | 0 | 2 |
| 2024-05 | 0 | 1 |
| 2024-06 | 0 | 14.5 |
| 2024-07 | 0 | 15 |
| 2024-08 | 4 | 4.33 |
| 2024-09 | 8 | 9.5 |
| 2024-10 | 6 | 3.8 |
| 2024-11 | 2 | 2.33 |
| 2024-12 | 6 | 4.67 |
| 2025-01 | 2 | 2.33 |
| 2025-02 | 0 | 2 |
| 2025-03 | 0 | 1 |
| 2025-04 | 2 | 2 |
| 2025-05 | 4 | 4.33 |
| 2025-06 | 0 | 3 |
| 2025-07 | 4 | 3.67 |
| 2025-08 | 2 | 2 |
| 2025-09 | 0 | 2 |
| 2025-10 | 4 | 3.33 |
| 2025-11 | 2 | 2.67 |
| 2025-12 | 4 | 3.25 |
| 2026-01 | 0 | 1.5 |
| 2026-02 | 0 | 1 |
| 2026-03 | 0 | 5 |
| 2026-04 | 0 | 1.25 |
| 2026-05 | 0 | 1 |
| 2026-06 | 0 | 1.33 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-12-31 | 1528319-2025-00118 | Malfunction | Available | catalog number |
| 2025-12-05 | 1528319-2025-00112 | Malfunction | Available | catalog number |
| 2025-11-14 | 1528319-2025-00104 | Malfunction | Available | catalog number |
| 2025-10-24 | 1528319-2025-00101 | Malfunction | Available | catalog number |
| 2025-10-10 | 1528319-2025-00100 | Malfunction | Available | catalog number |
| 2025-08-08 | 1528319-2025-00082 | Malfunction | Available | catalog number |
| 2025-07-09 | 22456505 | Malfunction | Available | catalog number |
| 2025-07-07 | 1528319-2025-00002 | Malfunction | Available | catalog number |
| 2025-05-23 | 1528319-2025-00043 | Malfunction | Available | catalog number |
| 2025-05-02 | 1528319-2025-00038 | Malfunction | Available | catalog number |
| 2025-04-03 | 1528319-2025-00025 | Malfunction | Available | catalog number |
| 2025-01-16 | 1528319-2025-00003 | Malfunction | Available | catalog number |
| 2024-12-23 | 1528319-2024-00113 | Malfunction | Available | catalog number |
| 2024-12-19 | 1528319-2024-00107 | Malfunction | Available | catalog number |
| 2024-12-17 | 20950901 | Malfunction | Available | catalog number |
Showing the most recent 33 of 60 linked reports.
Showing 1–15 of 33
Regulatory clearances
None linked.
Manufacturer compliance record
None in the loaded window.
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