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.
1 linked reportMalfunction 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-03 | 0 | 2 |
| 2019-05 | 0 | 10 |
| 2019-06 | 0 | 4 |
| 2019-07 | 0 | 3 |
| 2019-09 | 0 | 3 |
| 2019-11 | 0 | 2 |
| 2020-02 | 0 | 3 |
| 2020-03 | 0 | 1.5 |
| 2020-06 | 0 | 1 |
| 2020-11 | 0 | 2 |
| 2020-12 | 0 | 28 |
| 2021-01 | 0 | 2 |
| 2021-02 | 0 | 6 |
| 2021-03 | 0 | 2.4 |
| 2021-05 | 0 | 3 |
| 2021-06 | 0 | 3.5 |
| 2021-07 | 0 | 3 |
| 2021-09 | 0 | 3 |
| 2021-10 | 0 | 6 |
| 2021-11 | 0 | 3 |
| 2021-12 | 0 | 3 |
| 2022-02 | 0 | 1 |
| 2022-05 | 0 | 6 |
| 2022-06 | 0 | 1.5 |
| 2022-10 | 1 | 2 |
| 2023-04 | 0 | 3 |
| 2023-05 | 0 | 4.5 |
| 2023-06 | 0 | 3 |
| 2023-07 | 0 | 1 |
| 2023-11 | 0 | 13.5 |
| 2023-12 | 0 | 18 |
| 2024-01 | 0 | 1 |
| 2024-02 | 0 | 2 |
| 2024-03 | 0 | 1 |
| 2024-05 | 0 | 2 |
| 2024-06 | 0 | 9 |
| 2024-07 | 0 | 2 |
| 2024-09 | 0 | 3 |
| 2024-10 | 0 | 1 |
| 2024-11 | 0 | 3 |
| 2024-12 | 0 | 1 |
| 2025-01 | 0 | 12.5 |
| 2025-02 | 0 | 2 |
| 2025-03 | 0 | 2 |
| 2025-04 | 0 | 4.5 |
| 2025-05 | 0 | 3.33 |
| 2025-06 | 0 | 11 |
| 2025-07 | 0 | 1 |
| 2025-08 | 0 | 5.67 |
| 2025-09 | 0 | 1 |
| 2025-10 | 0 | 1.67 |
| 2025-11 | 0 | 4 |
| 2025-12 | 0 | 1.5 |
| 2026-01 | 0 | 3.67 |
| 2026-02 | 0 | 3.33 |
| 2026-03 | 0 | 1 |
| 2026-04 | 0 | 1 |
| 2026-05 | 0 | 2.5 |
| 2026-06 | 0 | 3.67 |
Failure-mode summaryAI-generated
1 linked report narrative available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2022-10-06 | 1319130-2022-00005 | Malfunction | Available | exact di |
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2016-03-03 | NAI | No action indicated | McKesson Medical-Surgical Inc | 0 |
| 2012-05-01 | NAI | No action indicated | McKesson Medical-Surgical Inc. | 0 |
| 2011-12-08 | NAI | No action indicated | McKesson Medical-Surgical | 2 |
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