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.
12 linked reportsMalfunction 12
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1 |
| 2019-06 | 0 | 2 |
| 2019-07 | 0 | 1.5 |
| 2019-08 | 0 | 2 |
| 2019-10 | 0 | 2 |
| 2019-12 | 0 | 3 |
| 2020-02 | 0 | 2 |
| 2020-03 | 0 | 2 |
| 2020-10 | 2 | 2 |
| 2020-12 | 0 | 1 |
| 2021-03 | 0 | 2 |
| 2021-05 | 0 | 2 |
| 2021-10 | 0 | 1 |
| 2021-11 | 0 | 2 |
| 2022-02 | 0 | 2 |
| 2022-05 | 2 | 2 |
| 2022-06 | 0 | 10 |
| 2022-08 | 2 | 2 |
| 2022-09 | 0 | 1 |
| 2022-10 | 0 | 2 |
| 2022-11 | 0 | 1.67 |
| 2022-12 | 0 | 2 |
| 2023-01 | 0 | 1 |
| 2023-02 | 0 | 1 |
| 2023-03 | 0 | 1 |
| 2023-04 | 0 | 2 |
| 2023-05 | 0 | 2 |
| 2023-06 | 2 | 1.5 |
| 2023-07 | 0 | 1 |
| 2023-08 | 0 | 1 |
| 2023-09 | 0 | 2 |
| 2023-12 | 0 | 1.5 |
| 2024-02 | 0 | 2 |
| 2024-03 | 0 | 2 |
| 2024-04 | 0 | 6 |
| 2024-06 | 0 | 1.67 |
| 2024-07 | 0 | 2 |
| 2024-08 | 0 | 2 |
| 2024-09 | 2 | 3 |
| 2024-10 | 0 | 1 |
| 2024-11 | 0 | 2 |
| 2025-01 | 0 | 2 |
| 2025-02 | 0 | 3 |
| 2025-04 | 0 | 2 |
| 2025-07 | 0 | 2 |
| 2025-09 | 0 | 2 |
| 2025-10 | 0 | 1 |
| 2025-11 | 2 | 2 |
| 2026-02 | 0 | 2.67 |
| 2026-03 | 0 | 2 |
| 2026-04 | 0 | 2 |
Failure-mode summaryAI-generated
12 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 | 2027111-2025-00866 | Malfunction | Available | exact di |
| 2024-09-19 | 2027111-2024-00831 | Malfunction | Available | exact di |
| 2023-06-12 | 2027111-2023-00491 | Malfunction | Available | exact di |
| 2022-08-10 | 2027111-2022-00696 | Malfunction | Available | exact di |
| 2022-05-09 | 2027111-2022-00593 | Malfunction | Available | exact di |
| 2020-10-02 | 2027111-2020-00571 | Malfunction | Available | exact di |
Showing the most recent 6 of 12 linked reports.
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2021-09-02 | NAI | No action indicated | Applied Medical Resources Corp | 0 |
| 2021-09-02 | NAI | No action indicated | Applied Medical Resources Corp | 0 |
| 2018-11-20 | NAI | No action indicated | Applied Medical Resources Corp | 0 |
| 2018-11-20 | NAI | No action indicated | Applied Medical Resources Corp | 0 |
| 2017-03-31 | VAI | Voluntary action indicated | Applied Medical Resources Corp | 0 |
| 2017-03-31 | VAI | Voluntary action indicated | Applied Medical Resources Corp | 0 |
| 2015-12-03 | NAI | No action indicated | Applied Medical Resources Corporation | 0 |
| 2015-10-14 | OAI | Official action indicated | Applied Medical Resources Corp | 8 |
| 2015-10-14 | OAI | Official action indicated | Applied Medical Resources Corp | 8 |
| 2015-04-10 | WL | Warning Letter | Applied Medical Resources Corp | — |
| 2015-04-10 | WL | Warning Letter | Applied Medical Resources Corp | — |
| 2014-12-16 | OAI | Official action indicated | Applied Medical Resources Corp | 8 |
| 2014-12-16 | NAI | No action indicated | Applied Medical Distribution Center | 0 |
| 2014-12-16 | OAI | Official action indicated | Applied Medical Resources Corp | 8 |
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