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 7Injury 2
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 18.5 |
| 2019-02 | 0 | 16.4 |
| 2019-03 | 0 | 17.17 |
| 2019-04 | 0 | 19.4 |
| 2019-05 | 0 | 12 |
| 2019-06 | 0 | 17.67 |
| 2019-07 | 0 | 23 |
| 2019-08 | 0 | 27 |
| 2019-09 | 0 | 36.25 |
| 2019-10 | 0 | 41.75 |
| 2019-11 | 0 | 27.4 |
| 2019-12 | 0 | 38.75 |
| 2020-01 | 0 | 31 |
| 2020-02 | 0 | 49 |
| 2020-03 | 0 | 30.25 |
| 2020-04 | 0 | 13.78 |
| 2020-05 | 0 | 18.29 |
| 2020-06 | 1 | 18.13 |
| 2020-07 | 0 | 31.75 |
| 2020-08 | 0 | 31.6 |
| 2020-09 | 0 | 31.2 |
| 2020-10 | 2 | 12.29 |
| 2020-11 | 0 | 26.4 |
| 2020-12 | 0 | 20.6 |
| 2021-01 | 0 | 17.63 |
| 2021-02 | 0 | 22.71 |
| 2021-03 | 0 | 17.73 |
| 2021-04 | 0 | 11.85 |
| 2021-05 | 0 | 15.11 |
| 2021-06 | 0 | 15.82 |
| 2021-07 | 0 | 11.91 |
| 2021-08 | 0 | 14.2 |
| 2021-09 | 0 | 14.73 |
| 2021-10 | 0 | 13.33 |
| 2021-11 | 0 | 15.6 |
| 2021-12 | 0 | 19.92 |
| 2022-01 | 0 | 11.6 |
| 2022-02 | 0 | 15.25 |
| 2022-03 | 0 | 13.36 |
| 2022-04 | 0 | 19.3 |
| 2022-05 | 0 | 22.27 |
| 2022-06 | 0 | 20.17 |
| 2022-07 | 0 | 20.17 |
| 2022-08 | 0 | 18.73 |
| 2022-09 | 0 | 11.75 |
| 2022-10 | 0 | 14.5 |
| 2022-11 | 0 | 33.67 |
| 2022-12 | 0 | 17.64 |
| 2023-01 | 0 | 20.75 |
| 2023-02 | 0 | 18.8 |
| 2023-03 | 0 | 20.8 |
| 2023-04 | 2 | 9.22 |
| 2023-05 | 0 | 14.67 |
| 2023-06 | 0 | 14.15 |
| 2023-07 | 0 | 20.56 |
| 2023-08 | 0 | 12.31 |
| 2023-09 | 0 | 17.7 |
| 2023-10 | 0 | 11.17 |
| 2023-11 | 0 | 12.4 |
| 2023-12 | 2 | 14.21 |
| 2024-01 | 0 | 12.75 |
| 2024-02 | 0 | 15.38 |
| 2024-03 | 0 | 12.5 |
| 2024-04 | 0 | 10.59 |
| 2024-05 | 0 | 9.72 |
| 2024-06 | 2 | 8 |
| 2024-07 | 0 | 8.45 |
| 2024-08 | 0 | 12.33 |
| 2024-09 | 0 | 15.41 |
| 2024-10 | 0 | 10.29 |
| 2024-11 | 0 | 8.05 |
| 2024-12 | 0 | 7.73 |
| 2025-01 | 0 | 7.91 |
| 2025-02 | 0 | 7.94 |
| 2025-03 | 0 | 6.85 |
| 2025-04 | 0 | 7.11 |
| 2025-05 | 0 | 7.65 |
| 2025-06 | 0 | 9.29 |
| 2025-07 | 0 | 8.31 |
| 2025-08 | 0 | 7.33 |
| 2025-09 | 0 | 8.29 |
| 2025-10 | 0 | 9 |
| 2025-11 | 0 | 7.5 |
| 2025-12 | 0 | 7.67 |
| 2026-01 | 0 | 5.71 |
| 2026-02 | 0 | 9.62 |
| 2026-03 | 0 | 9.7 |
| 2026-04 | 0 | 6.67 |
| 2026-05 | 0 | 6.73 |
| 2026-06 | 0 | 7.5 |
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 |
|---|---|---|---|---|
| 2024-06-28 | MW5156842 | Malfunction | Available | catalog number |
| 2024-06-28 | MW5156844 | Malfunction | Available | catalog number |
| 2023-12-05 | 2110898-2023-00098 | Injury | Available | catalog number |
| 2023-04-10 | 16706918 | Malfunction | Available | catalog number |
| 2020-10-02 | 10619298 | Malfunction | Available | catalog number |
| 2020-06-04 | 10118197 | Malfunction | Available | catalog number |
Showing the most recent 6 of 9 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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