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.
9 linked reportsMalfunction 8Injury 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.41 |
| 2019-02 | 0 | 1.71 |
| 2019-03 | 0 | 3 |
| 2019-04 | 0 | 2.46 |
| 2019-05 | 0 | 1.89 |
| 2019-06 | 0 | 2.33 |
| 2019-07 | 0 | 2.48 |
| 2019-08 | 0 | 2 |
| 2019-09 | 0 | 1 |
| 2019-10 | 0 | 2.59 |
| 2019-11 | 0 | 1.8 |
| 2019-12 | 0 | 2.5 |
| 2020-01 | 0 | 2.8 |
| 2020-02 | 0 | 2.5 |
| 2020-03 | 0 | 1.17 |
| 2020-04 | 0 | 3 |
| 2020-05 | 1 | 2.8 |
| 2020-06 | 0 | 1.67 |
| 2020-07 | 0 | 2.92 |
| 2020-08 | 0 | 1.15 |
| 2020-09 | 0 | 1.5 |
| 2020-10 | 0 | 2.92 |
| 2020-11 | 0 | 2.25 |
| 2020-12 | 0 | 1 |
| 2021-01 | 0 | 4.96 |
| 2021-02 | 0 | 3.35 |
| 2021-03 | 0 | 1.67 |
| 2021-04 | 0 | 2.43 |
| 2021-05 | 0 | 2 |
| 2021-06 | 0 | 1.89 |
| 2021-07 | 0 | 2.47 |
| 2021-08 | 0 | 1.6 |
| 2021-09 | 0 | 1.2 |
| 2021-10 | 0 | 2.83 |
| 2021-11 | 0 | 1.17 |
| 2021-12 | 0 | 1.67 |
| 2022-01 | 0 | 2.72 |
| 2022-02 | 0 | 1 |
| 2022-03 | 0 | 1.75 |
| 2022-04 | 0 | 3.1 |
| 2022-05 | 0 | 2.33 |
| 2022-06 | 0 | 1 |
| 2022-07 | 0 | 3.23 |
| 2022-08 | 0 | 1.75 |
| 2022-09 | 0 | 4 |
| 2022-10 | 0 | 3.29 |
| 2022-11 | 0 | 1.43 |
| 2022-12 | 0 | 2 |
| 2023-01 | 0 | 3.16 |
| 2023-02 | 0 | 1.67 |
| 2023-03 | 0 | 2.3 |
| 2023-04 | 0 | 3.68 |
| 2023-05 | 0 | 2.33 |
| 2023-06 | 0 | 2.4 |
| 2023-07 | 1 | 3.68 |
| 2023-08 | 1 | 1.63 |
| 2023-09 | 1 | 1.77 |
| 2023-10 | 0 | 3.5 |
| 2023-11 | 0 | 2.5 |
| 2023-12 | 0 | 2.4 |
| 2024-01 | 0 | 3.57 |
| 2024-02 | 1 | 3.17 |
| 2024-03 | 1 | 1.71 |
| 2024-04 | 0 | 4.21 |
| 2024-05 | 0 | 1.43 |
| 2024-06 | 0 | 2.3 |
| 2024-07 | 0 | 3.51 |
| 2024-08 | 1 | 1.57 |
| 2024-09 | 0 | 7 |
| 2024-10 | 0 | 4 |
| 2024-11 | 1 | 5.43 |
| 2024-12 | 0 | 4.6 |
| 2025-01 | 0 | 3.77 |
| 2025-02 | 0 | 6.67 |
| 2025-03 | 1 | 8 |
| 2025-04 | 0 | 3.81 |
| 2025-05 | 0 | 6 |
| 2025-06 | 0 | 3 |
| 2025-07 | 0 | 3.23 |
| 2025-08 | 0 | 5.67 |
| 2025-09 | 0 | 5 |
| 2025-10 | 0 | 3.47 |
| 2025-11 | 0 | 5.67 |
| 2025-12 | 0 | 3.22 |
| 2026-01 | 0 | 3.13 |
| 2026-02 | 0 | 4.67 |
| 2026-03 | 0 | 5.11 |
| 2026-04 | 0 | 3.84 |
| 2026-05 | 0 | 10.43 |
| 2026-06 | 0 | 7.43 |
Failure-mode summaryAI-generated
9 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-03-04 | 1523574-2025-00018 | Malfunction | Available | model number |
| 2024-11-04 | 1523574-2024-00075 | Malfunction | Available | model number |
| 2024-08-01 | 1523574-2024-00057 | Malfunction | Available | model number |
| 2024-03-01 | 1523574-2024-00016 | Malfunction | Available | model number |
| 2024-02-10 | 1523574-2024-00011 | Malfunction | Available | model number |
| 2023-09-29 | 1523574-2023-00029 | Malfunction | Available | model number |
| 2023-08-18 | 1523574-2023-00033 | Malfunction | Available | model number |
| 2023-07-28 | 1523574-2023-00026 | Malfunction | Available | model number |
| 2020-05-01 | 1523574-2020-00012 | Injury | Available | model number |
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2023-01-24 | VAI | Voluntary action indicated | Ferno-Washington Inc | 6 |
| 2023-01-24 | VAI | Voluntary action indicated | Ferno-Washington Inc | 6 |
| 2018-07-23 | NAI | No action indicated | Ferno-Washington Inc | 0 |
| 2018-07-23 | NAI | No action indicated | Ferno-Washington Inc | 0 |
| 2015-03-11 | VAI | Voluntary action indicated | Ferno-Washington Inc | 6 |
| 2015-03-11 | VAI | Voluntary action indicated | Ferno-Washington Inc | 6 |
| 2011-09-29 | VAI | Voluntary action indicated | Ferno-Washington Inc | 6 |
| 2011-09-29 | VAI | Voluntary action indicated | Ferno-Washington Inc | 6 |
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