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.
15 linked reportsInjury 13Malfunction 2
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 14.01 |
| 2019-02 | 0 | 19.34 |
| 2019-03 | 0 | 21.77 |
| 2019-04 | 0 | 28.26 |
| 2019-05 | 0 | 26.14 |
| 2019-06 | 0 | 24.19 |
| 2019-07 | 0 | 24.82 |
| 2019-08 | 0 | 22.58 |
| 2019-09 | 2 | 20.42 |
| 2019-10 | 0 | 22.67 |
| 2019-11 | 0 | 16.37 |
| 2019-12 | 0 | 19.89 |
| 2020-01 | 0 | 22.19 |
| 2020-02 | 0 | 18.44 |
| 2020-03 | 0 | 20.57 |
| 2020-04 | 0 | 17.63 |
| 2020-05 | 0 | 24.77 |
| 2020-06 | 0 | 30.27 |
| 2020-07 | 0 | 18.51 |
| 2020-08 | 0 | 12.33 |
| 2020-09 | 0 | 19.58 |
| 2020-10 | 0 | 12.45 |
| 2020-11 | 0 | 18.13 |
| 2020-12 | 0 | 18.98 |
| 2021-01 | 0 | 16.35 |
| 2021-02 | 0 | 17.07 |
| 2021-03 | 0 | 18.21 |
| 2021-04 | 1 | 19.62 |
| 2021-05 | 0 | 20 |
| 2021-06 | 0 | 19.7 |
| 2021-07 | 0 | 28.06 |
| 2021-08 | 0 | 17.13 |
| 2021-09 | 0 | 21.17 |
| 2021-10 | 0 | 19.14 |
| 2021-11 | 0 | 16.63 |
| 2021-12 | 0 | 23.6 |
| 2022-01 | 0 | 16.23 |
| 2022-02 | 0 | 15.33 |
| 2022-03 | 1 | 17.98 |
| 2022-04 | 0 | 16.62 |
| 2022-05 | 0 | 18.6 |
| 2022-06 | 1 | 14.8 |
| 2022-07 | 1 | 14.55 |
| 2022-08 | 0 | 8 |
| 2022-09 | 0 | 9.32 |
| 2022-10 | 0 | 8.08 |
| 2022-11 | 0 | 11.65 |
| 2022-12 | 0 | 7.24 |
| 2023-01 | 0 | 13.11 |
| 2023-02 | 0 | 9.6 |
| 2023-03 | 0 | 9.9 |
| 2023-04 | 0 | 7.78 |
| 2023-05 | 3 | 36.62 |
| 2023-06 | 1 | 23.03 |
| 2023-07 | 0 | 13.17 |
| 2023-08 | 0 | 11.24 |
| 2023-09 | 0 | 6.48 |
| 2023-10 | 0 | 6.48 |
| 2023-11 | 0 | 4.73 |
| 2023-12 | 0 | 4.39 |
| 2024-01 | 0 | 8.58 |
| 2024-02 | 0 | 2.73 |
| 2024-03 | 1 | 7.97 |
| 2024-04 | 2 | 4.02 |
| 2024-05 | 0 | 7.3 |
| 2024-06 | 0 | 5.13 |
| 2024-07 | 0 | 3.64 |
| 2024-08 | 2 | 3.3 |
| 2024-09 | 0 | 3.83 |
| 2024-10 | 0 | 4.44 |
| 2024-11 | 0 | 2.81 |
| 2024-12 | 0 | 5.57 |
| 2025-01 | 0 | 5.49 |
| 2025-02 | 0 | 2.66 |
| 2025-03 | 0 | 2.86 |
| 2025-04 | 0 | 3.69 |
| 2025-05 | 0 | 4.88 |
| 2025-06 | 0 | 3.09 |
| 2025-07 | 0 | 3.13 |
| 2025-08 | 0 | 4.73 |
| 2025-09 | 0 | 2.75 |
| 2025-10 | 0 | 3.59 |
| 2025-11 | 0 | 3.6 |
| 2025-12 | 0 | 2.64 |
| 2026-01 | 0 | 4.2 |
| 2026-02 | 0 | 2.35 |
| 2026-03 | 0 | 3.51 |
| 2026-04 | 0 | 3.03 |
| 2026-05 | 0 | 3.02 |
| 2026-06 | 0 | 4.17 |
Failure-mode summaryAI-generated
15 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2024-08-26 | 3005621222-2024-00010 | Injury | Available | exact di |
| 2024-08-12 | 1832816-2024-00013 | Injury | Available | exact di |
| 2024-04-12 | 1832816-2024-00008 | Injury | Available | exact di |
| 2024-04-12 | 1832816-2024-00009 | Injury | Available | exact di |
| 2024-03-19 | 1832816-2024-00007 | Injury | Available | exact di |
| 2023-06-05 | 3005621222-2023-00007 | Injury | Available | exact di |
| 2023-05-18 | 3005621222-2023-00005 | Injury | Available | exact di |
| 2023-05-05 | 1832816-2023-00007 | Injury | Available | exact di |
| 2023-05-05 | 1832816-2023-00012 | Injury | Available | exact di |
| 2022-07-28 | 3005621222-2022-00007 | Injury | Available | exact di |
| 2022-06-28 | 1832816-2022-00008 | Injury | Available | exact di |
| 2022-03-08 | 3005621222-2022-00001 | Malfunction | Available | exact di |
| 2021-04-23 | 3005621222-2021-00006 | Malfunction | Available | exact di |
| 2019-09-11 | 1832816-2019-00018 | Injury | Available | exact di |
| 2019-09-11 | 1832816-2019-00017 | Injury | Available | exact di |
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2015-04-10 | WL | Warning Letter | ARKRAY, Inc. | — |
| 2014-10-10 | OAI | Official action indicated | ARKRAY, Inc. | 6 |
| 2011-08-02 | NAI | No action indicated | ARKRAY, Inc. | 0 |
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