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.
10 linked reportsMalfunction 10
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-04 | 0 | 1 |
| 2019-07 | 0 | 1 |
| 2021-04 | 0 | 1 |
| 2022-01 | 0 | 1 |
| 2023-06 | 0 | 1 |
| 2023-10 | 0 | 2 |
| 2024-04 | 0 | 1 |
| 2024-08 | 0 | 1 |
| 2025-01 | 0 | 1 |
| 2025-02 | 2 | 2 |
| 2025-03 | 0 | 4 |
| 2025-04 | 0 | 1 |
| 2025-05 | 0 | 2 |
| 2025-06 | 0 | 5 |
| 2025-07 | 2 | 2 |
| 2025-08 | 2 | 2 |
| 2025-09 | 2 | 2 |
| 2025-11 | 2 | 2 |
| 2026-01 | 0 | 4.5 |
| 2026-05 | 0 | 2.5 |
Failure-mode summaryAI-generated
10 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-11-18 | 1523574-2025-00104 | Malfunction | Available | exact di |
| 2025-09-24 | 1523574-2025-00093 | Malfunction | Available | exact di |
| 2025-08-12 | 1523574-2025-00086 | Malfunction | Available | exact di |
| 2025-07-03 | 1523574-2025-00068 | Malfunction | Available | exact di |
| 2025-02-25 | 1523574-2025-00017 | Malfunction | Available | exact di |
Showing the most recent 5 of 10 linked reports.
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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