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.
4 linked reportsMalfunction 3Injury 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1 |
| 2019-02 | 0 | 1.25 |
| 2019-03 | 0 | 1 |
| 2019-04 | 0 | 1 |
| 2019-05 | 0 | 1 |
| 2019-07 | 0 | 2.67 |
| 2019-10 | 0 | 1.5 |
| 2019-12 | 0 | 2.5 |
| 2020-01 | 0 | 1.5 |
| 2020-02 | 0 | 1 |
| 2020-03 | 0 | 4 |
| 2020-04 | 0 | 1 |
| 2020-05 | 0 | 2 |
| 2020-08 | 0 | 1 |
| 2020-09 | 0 | 1 |
| 2020-10 | 1 | 1.33 |
| 2020-12 | 0 | 1.4 |
| 2021-02 | 3 | 2.63 |
| 2021-06 | 0 | 6 |
| 2021-07 | 0 | 2 |
| 2021-09 | 0 | 3 |
| 2021-10 | 0 | 1 |
| 2021-11 | 0 | 1 |
| 2021-12 | 0 | 1.8 |
| 2022-02 | 0 | 1 |
| 2022-03 | 0 | 1 |
| 2022-07 | 0 | 1 |
| 2022-08 | 0 | 1.6 |
| 2022-10 | 0 | 2 |
| 2022-11 | 0 | 1 |
| 2023-01 | 0 | 3 |
| 2023-04 | 0 | 1.5 |
| 2023-05 | 0 | 1 |
| 2023-06 | 0 | 2.25 |
| 2023-07 | 0 | 3 |
| 2023-08 | 0 | 1.67 |
| 2023-10 | 0 | 1 |
| 2023-11 | 0 | 1.5 |
| 2024-02 | 0 | 2 |
| 2024-03 | 0 | 1 |
| 2024-05 | 0 | 2 |
| 2024-09 | 0 | 2 |
| 2024-11 | 0 | 3 |
| 2024-12 | 0 | 1 |
| 2025-01 | 0 | 1.5 |
| 2025-03 | 0 | 3 |
| 2025-04 | 0 | 3 |
| 2025-05 | 0 | 4 |
| 2025-12 | 0 | 2.25 |
| 2026-01 | 0 | 1 |
| 2026-02 | 0 | 3 |
| 2026-03 | 0 | 2 |
| 2026-04 | 0 | 2 |
| 2026-05 | 0 | 2 |
| 2026-06 | 0 | 1.5 |
Failure-mode summaryAI-generated
4 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2021-02-11 | MW5099350 | Malfunction | Available | model number |
| 2021-02-10 | 11307580 | Malfunction | Available | catalog number |
| 2020-10-05 | MW5097093 | Injury | Available | model number |
Showing the most recent 3 of 4 linked reports.
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2026-06-24 | NAI | No action indicated | 3m Company | 0 |
| 2026-06-24 | NAI | No action indicated | 3m Company | 0 |
| 2019-04-17 | VAI | Voluntary action indicated | 3M | 4 |
| 2017-11-27 | NAI | No action indicated | 3M Company | 0 |
| 2016-12-08 | NAI | No action indicated | 3M Company | 0 |
| 2016-12-08 | NAI | No action indicated | 3M Company | 0 |
| 2016-12-06 | NAI | No action indicated | 3M Company | 0 |
| 2016-09-14 | NAI | No action indicated | 3M Company | 0 |
| 2015-11-06 | VAI | Voluntary action indicated | 3M Company | 1 |
| 2015-03-19 | OAI | Official action indicated | 3m Canada Company | 5 |
| 2014-07-09 | NAI | No action indicated | 3M Co | 0 |
| 2014-07-09 | NAI | No action indicated | 3M Co | 0 |
| 2014-06-26 | NAI | No action indicated | 3M Company | 0 |
| 2014-06-26 | NAI | No action indicated | 3M Company | 0 |
| 2014-04-25 | NAI | No action indicated | 3M Company | 0 |
| 2013-12-13 | NAI | No action indicated | 3M Company | 0 |
| 2013-08-16 | NAI | No action indicated | 3m Company | 0 |
| 2013-08-16 | NAI | No action indicated | 3m Company | 0 |
| 2013-03-28 | NAI | No action indicated | 3M Company | 1 |
| 2012-12-05 | NAI | No action indicated | 3M COMPANY | 0 |
| 2010-06-07 | WL | Warning Letter | 3M Company | — |
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