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 9
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-02 | 0 | 1 |
| 2019-04 | 0 | 1 |
| 2019-05 | 0 | 1.2 |
| 2019-06 | 0 | 2 |
| 2019-07 | 0 | 1 |
| 2019-09 | 0 | 1 |
| 2019-10 | 1 | 1 |
| 2019-11 | 0 | 2 |
| 2019-12 | 1 | 1.33 |
| 2020-01 | 0 | 3 |
| 2020-02 | 0 | 4 |
| 2020-07 | 0 | 1 |
| 2020-10 | 0 | 1.5 |
| 2020-11 | 0 | 1 |
| 2020-12 | 0 | 2 |
| 2021-01 | 0 | 1.67 |
| 2021-02 | 0 | 3.5 |
| 2021-03 | 0 | 1 |
| 2021-05 | 0 | 1.5 |
| 2021-06 | 0 | 2 |
| 2021-08 | 0 | 3 |
| 2021-09 | 0 | 1 |
| 2021-10 | 1 | 1 |
| 2021-11 | 0 | 1 |
| 2021-12 | 0 | 2 |
| 2022-02 | 0 | 1 |
| 2022-03 | 1 | 1 |
| 2022-04 | 0 | 1.5 |
| 2022-05 | 0 | 4.5 |
| 2022-06 | 0 | 1.67 |
| 2022-07 | 0 | 1 |
| 2022-08 | 0 | 1.33 |
| 2022-09 | 0 | 1.6 |
| 2022-10 | 0 | 1 |
| 2022-11 | 0 | 1 |
| 2022-12 | 0 | 1 |
| 2023-01 | 1 | 1 |
| 2023-02 | 0 | 1 |
| 2023-03 | 1 | 1 |
| 2023-04 | 0 | 2 |
| 2023-05 | 0 | 1.67 |
| 2023-06 | 0 | 1.75 |
| 2023-07 | 0 | 8 |
| 2023-08 | 0 | 1 |
| 2023-09 | 0 | 1 |
| 2023-10 | 0 | 1.25 |
| 2023-11 | 0 | 2 |
| 2023-12 | 0 | 1 |
| 2024-03 | 0 | 1 |
| 2024-04 | 1 | 1 |
| 2024-05 | 0 | 1.33 |
| 2024-06 | 0 | 1.5 |
| 2024-07 | 0 | 1.25 |
| 2024-08 | 0 | 1 |
| 2024-10 | 0 | 1 |
| 2024-12 | 0 | 1.25 |
| 2025-01 | 0 | 1.33 |
| 2025-02 | 0 | 1 |
| 2025-03 | 0 | 2 |
| 2025-04 | 0 | 1 |
| 2025-05 | 0 | 1 |
| 2025-06 | 0 | 2 |
| 2025-08 | 1 | 1 |
| 2025-09 | 0 | 1 |
| 2025-10 | 0 | 2 |
| 2025-12 | 0 | 1 |
| 2026-01 | 1 | 1.67 |
| 2026-02 | 0 | 1.33 |
| 2026-03 | 0 | 1 |
| 2026-04 | 0 | 1.25 |
| 2026-05 | 0 | 1.4 |
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 |
|---|---|---|---|---|
| 2026-01-16 | 3012811961-2026-00001 | Malfunction | Available | exact di |
| 2025-08-28 | 3012811961-2025-00008 | Malfunction | Available | exact di |
| 2024-04-25 | 8043817-2024-00009 | Malfunction | Available | exact di |
| 2023-03-23 | 3012811961-2023-00004 | Malfunction | Available | exact di |
| 2023-01-13 | 3012811961-2023-00002 | Malfunction | Available | exact di |
| 2022-03-18 | 3012811961-2022-00001 | Malfunction | Available | exact di |
| 2021-10-27 | MW5104996 | Malfunction | Available | exact di |
| 2019-12-06 | 8043817-2019-40036 | Malfunction | Available | exact di |
| 2019-10-21 | 8043817-2019-40030 | Malfunction | Available | exact di |
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2025-04-22 | NAI | No action indicated | MICROTEK MEDICAL LLC | 0 |
| 2018-06-15 | NAI | No action indicated | MICROTEK MEDICAL LLC | 0 |
| 2016-08-03 | VAI | Voluntary action indicated | Microtek Medical Inc | 4 |
| 2011-06-22 | NAI | No action indicated | Microtek Medical Inc | 0 |
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