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.
7 linked reportsInjury 7
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1 |
| 2019-02 | 0 | 2 |
| 2019-03 | 0 | 3 |
| 2019-04 | 0 | 1.33 |
| 2019-05 | 0 | 1 |
| 2019-06 | 0 | 1 |
| 2019-07 | 0 | 3 |
| 2019-08 | 0 | 1.38 |
| 2019-10 | 0 | 2 |
| 2019-11 | 3 | 2.86 |
| 2019-12 | 0 | 2 |
| 2020-02 | 0 | 1 |
| 2020-04 | 0 | 3 |
| 2020-06 | 0 | 1.5 |
| 2020-07 | 0 | 1.5 |
| 2020-09 | 0 | 1 |
| 2020-10 | 0 | 2 |
| 2020-11 | 4 | 3.22 |
| 2020-12 | 0 | 4.5 |
| 2021-01 | 0 | 1 |
| 2021-02 | 0 | 2 |
| 2021-03 | 0 | 3 |
| 2021-05 | 0 | 36 |
| 2021-06 | 0 | 1 |
| 2021-07 | 0 | 2 |
| 2021-09 | 0 | 3 |
| 2021-11 | 0 | 2 |
| 2021-12 | 0 | 1.67 |
| 2022-01 | 0 | 1 |
| 2022-04 | 0 | 4 |
| 2022-05 | 0 | 2 |
| 2022-06 | 0 | 20 |
| 2022-07 | 0 | 2.5 |
| 2022-10 | 0 | 3 |
| 2022-11 | 0 | 6.33 |
| 2022-12 | 0 | 3 |
| 2023-01 | 0 | 2.67 |
| 2023-02 | 0 | 3 |
| 2023-03 | 0 | 12 |
| 2023-04 | 0 | 6.5 |
| 2023-05 | 0 | 12 |
| 2023-06 | 0 | 3 |
| 2023-07 | 0 | 1 |
| 2023-11 | 0 | 4.5 |
| 2023-12 | 0 | 2 |
| 2024-03 | 0 | 2 |
| 2024-04 | 0 | 1 |
| 2024-06 | 0 | 4 |
| 2024-08 | 0 | 10 |
| 2024-09 | 0 | 1 |
| 2024-10 | 0 | 27 |
| 2024-11 | 0 | 3 |
| 2024-12 | 0 | 1 |
| 2025-01 | 0 | 2 |
| 2025-05 | 0 | 1 |
| 2025-09 | 0 | 2 |
| 2025-10 | 0 | 6.67 |
| 2025-11 | 0 | 30.5 |
| 2026-03 | 0 | 1.5 |
| 2026-04 | 0 | 2 |
| 2026-06 | 0 | 2 |
Failure-mode summaryAI-generated
7 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2020-11-03 | 3012664855-2020-00011 | Injury | Available | catalog number |
| 2020-11-03 | 3012664855-2020-00016 | Injury | Available | catalog number |
| 2020-11-03 | 3012664855-2020-00015 | Injury | Available | catalog number |
| 2020-11-03 | 3012664855-2020-00009 | Injury | Available | catalog number |
| 2019-11-25 | 3010805634-2019-00003 | Injury | Available | catalog number |
| 2019-11-25 | 3010805634-2019-00002 | Injury | Available | catalog number |
| 2019-11-25 | 3010805634-2019-00006 | Injury | Available | catalog number |
Regulatory clearances
Predicate lineage
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
None in the loaded window.
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