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.
71 linked reportsMalfunction 61Death 6Injury 4
| 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 | 0 | 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 | 0 | 3.68 |
| 2023-08 | 0 | 1.63 |
| 2023-09 | 0 | 1.77 |
| 2023-10 | 0 | 3.5 |
| 2023-11 | 0 | 2.5 |
| 2023-12 | 0 | 2.4 |
| 2024-01 | 0 | 3.57 |
| 2024-02 | 0 | 3.17 |
| 2024-03 | 0 | 1.71 |
| 2024-04 | 0 | 4.21 |
| 2024-05 | 0 | 1.43 |
| 2024-06 | 0 | 2.3 |
| 2024-07 | 0 | 3.51 |
| 2024-08 | 0 | 1.57 |
| 2024-09 | 0 | 7 |
| 2024-10 | 0 | 4 |
| 2024-11 | 0 | 5.43 |
| 2024-12 | 0 | 4.6 |
| 2025-01 | 0 | 3.77 |
| 2025-02 | 0 | 6.67 |
| 2025-03 | 0 | 8 |
| 2025-04 | 0 | 3.81 |
| 2025-05 | 0 | 6 |
| 2025-06 | 2 | 3 |
| 2025-07 | 0 | 3.23 |
| 2025-08 | 0 | 5.67 |
| 2025-09 | 6 | 5 |
| 2025-10 | 0 | 3.47 |
| 2025-11 | 3 | 5.67 |
| 2025-12 | 3 | 3.22 |
| 2026-01 | 0 | 3.13 |
| 2026-02 | 0 | 4.67 |
| 2026-03 | 3 | 5.11 |
| 2026-04 | 15 | 3.84 |
| 2026-05 | 30 | 10.43 |
| 2026-06 | 9 | 7.43 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2025-09-11 | Z-0133-2026 | Class II | Open, Classified | The fastening post hardware could loosen allowing the fastening post to detach from the cotDistribution: US Nationwide distribution in the states of AL, AR, AZ, CA, CO, FL, IS, IL, KY, LA, MN, MO, NC, ND, NE, NM, NY, OH, OK, PA, TN, TX, UT, VA, WI, WV. | 138 units | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-06-08 | 1523574-2026-00063 | Malfunction | Available | catalog number |
| 2026-06-04 | 1523574-2026-00059 | Malfunction | Available | catalog number |
| 2026-06-02 | 1523574-2026-00061 | Death | Available | catalog number |
| 2026-05-20 | 1523574-2026-00049 | Malfunction | Available | catalog number |
| 2026-05-20 | 1523574-2026-00062 | Malfunction | Available | catalog number |
| 2026-05-20 | 1523574-2026-00052 | Malfunction | Available | catalog number |
| 2026-05-20 | 1523574-2026-00051 | Injury | Available | catalog number |
| 2026-05-20 | 1523574-2026-00050 | Malfunction | Available | catalog number |
| 2026-05-14 | 1523574-2026-00057 | Malfunction | Available | catalog number |
| 2026-05-08 | 1523574-2026-00043 | Injury | Available | catalog number |
| 2026-05-08 | 1523574-2026-00053 | Malfunction | Available | catalog number |
| 2026-05-08 | 1523574-2026-00048 | Malfunction | Available | catalog number |
| 2026-05-08 | 1523574-2026-00044 | Malfunction | Available | catalog number |
| 2026-05-08 | 1523574-2026-00047 | Malfunction | Available | catalog number |
| 2026-05-08 | 1523574-2026-00045 | Malfunction | Available | catalog number |
Showing the most recent 28 of 71 linked reports.
Showing 1–15 of 28
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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