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.
2 linked reportsInjury 2
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1.52 |
| 2019-02 | 0 | 1.36 |
| 2019-03 | 0 | 1.44 |
| 2019-04 | 0 | 1.37 |
| 2019-05 | 0 | 1.6 |
| 2019-06 | 0 | 1.13 |
| 2019-07 | 0 | 1.34 |
| 2019-08 | 2 | 1.35 |
| 2019-09 | 0 | 1.47 |
| 2019-10 | 0 | 1.46 |
| 2019-11 | 0 | 1.39 |
| 2019-12 | 0 | 1.52 |
| 2020-01 | 0 | 1.45 |
| 2020-02 | 0 | 1.7 |
| 2020-03 | 0 | 1.52 |
| 2020-04 | 0 | 1.42 |
| 2020-05 | 0 | 1.43 |
| 2020-06 | 0 | 1.43 |
| 2020-07 | 0 | 1.55 |
| 2020-08 | 0 | 1.33 |
| 2020-09 | 0 | 1.45 |
| 2020-10 | 0 | 1.55 |
| 2020-11 | 0 | 1.49 |
| 2020-12 | 0 | 1.57 |
| 2021-01 | 0 | 1.59 |
| 2021-02 | 0 | 1.42 |
| 2021-03 | 0 | 1.56 |
| 2021-04 | 0 | 1.44 |
| 2021-05 | 0 | 1.55 |
| 2021-06 | 0 | 1.65 |
| 2021-07 | 0 | 1.45 |
| 2021-08 | 0 | 1.5 |
| 2021-09 | 0 | 1.43 |
| 2021-10 | 0 | 1.57 |
| 2021-11 | 0 | 1.32 |
| 2021-12 | 0 | 1.31 |
| 2022-01 | 0 | 1.4 |
| 2022-02 | 0 | 1.3 |
| 2022-03 | 0 | 1.48 |
| 2022-04 | 0 | 1.37 |
| 2022-05 | 0 | 1.5 |
| 2022-06 | 0 | 1.39 |
| 2022-07 | 0 | 1.33 |
| 2022-08 | 0 | 1.34 |
| 2022-09 | 0 | 1.4 |
| 2022-10 | 0 | 1.37 |
| 2022-11 | 0 | 1.38 |
| 2022-12 | 0 | 1.43 |
| 2023-01 | 0 | 1.37 |
| 2023-02 | 0 | 1.33 |
| 2023-03 | 0 | 1.38 |
| 2023-04 | 0 | 1.42 |
| 2023-05 | 0 | 1.34 |
| 2023-06 | 0 | 1.23 |
| 2023-07 | 0 | 1.32 |
| 2023-08 | 0 | 1.3 |
| 2023-09 | 0 | 1.23 |
| 2023-10 | 0 | 1.18 |
| 2023-11 | 0 | 1.26 |
| 2023-12 | 0 | 1.21 |
| 2024-01 | 0 | 1.26 |
| 2024-02 | 0 | 1.28 |
| 2024-03 | 0 | 1.41 |
| 2024-04 | 0 | 1.15 |
| 2024-05 | 0 | 1.2 |
| 2024-06 | 0 | 1.29 |
| 2024-07 | 0 | 1.32 |
| 2024-08 | 0 | 1.19 |
| 2024-09 | 0 | 1.15 |
| 2024-10 | 0 | 1.24 |
| 2024-11 | 0 | 1.31 |
| 2024-12 | 0 | 1.19 |
| 2025-01 | 0 | 1.34 |
| 2025-02 | 0 | 1.25 |
| 2025-03 | 0 | 1.65 |
| 2025-04 | 0 | 1.57 |
| 2025-05 | 0 | 1.32 |
| 2025-06 | 0 | 1.56 |
| 2025-07 | 0 | 1.59 |
| 2025-08 | 0 | 1.23 |
| 2025-09 | 0 | 1.39 |
| 2025-10 | 0 | 1.46 |
| 2025-11 | 0 | 1.39 |
| 2025-12 | 0 | 1.56 |
| 2026-01 | 0 | 1.64 |
| 2026-02 | 0 | 1.24 |
| 2026-03 | 0 | 1.45 |
| 2026-04 | 0 | 1.6 |
| 2026-05 | 0 | 1.11 |
| 2026-06 | 0 | 1.37 |
Failure-mode summaryAI-generated
2 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2019-08-08 | 1644408-2019-00763 | Injury | Available | exact di |
Showing the most recent 1 of 2 linked reports.
Regulatory clearances
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2021-10-28 | VAI | Voluntary action indicated | Encore Medical, LP | 2 |
| 2020-03-11 | NAI | No action indicated | Encore Medical, LP | 0 |
| 2015-07-24 | NAI | No action indicated | Encore Medical, LP | 0 |
| 2013-06-28 | VAI | Voluntary action indicated | Encore Medical, LP | 2 |
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