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.
5 linked reportsInjury 5
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-02 | 0 | 1 |
| 2019-10 | 0 | 1 |
| 2020-02 | 0 | 1 |
| 2020-03 | 0 | 3 |
| 2020-11 | 0 | 1 |
| 2020-12 | 0 | 1.5 |
| 2023-04 | 0 | 1 |
| 2023-05 | 0 | 1 |
| 2023-08 | 0 | 1 |
| 2024-04 | 3 | 2.33 |
| 2024-05 | 1 | 1 |
| 2024-08 | 0 | 2 |
| 2024-10 | 0 | 1 |
| 2025-02 | 1 | 1 |
| 2025-03 | 0 | 1 |
| 2025-04 | 0 | 1 |
| 2025-05 | 0 | 2 |
| 2026-01 | 0 | 8 |
| 2026-02 | 0 | 1 |
| 2026-06 | 0 | 1 |
Failure-mode summaryAI-generated
5 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-02-10 | 3004558433-2025-00001 | Injury | Available | exact di |
| 2024-05-22 | 3004558433-2024-00005 | Injury | Available | exact di |
| 2024-04-09 | 3004558433-2024-00002 | Injury | Available | exact di |
| 2024-04-09 | 3004558433-2024-00003 | Injury | Available | exact di |
| 2024-04-09 | 3004558433-2024-00001 | Injury | Available | exact di |
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2026-05-26 | VAI | Voluntary action indicated | Biowave Corporation | 3 |
| 2026-05-26 | VAI | Voluntary action indicated | Biowave Corporation | 3 |
| 2023-06-21 | VAI | Voluntary action indicated | Biowave Corporation | 4 |
| 2023-06-21 | VAI | Voluntary action indicated | Biowave Corporation | 4 |
| 2017-04-27 | VAI | Voluntary action indicated | Biowave Corporation | 2 |
| 2017-04-27 | VAI | Voluntary action indicated | Biowave Corporation | 2 |
| 2013-08-28 | VAI | Voluntary action indicated | Biowave Corporation | 6 |
| 2013-08-28 | VAI | Voluntary action indicated | Biowave Corporation | 6 |
| 2011-02-18 | NAI | No action indicated | Biowave Corporation | 0 |
| 2011-02-18 | NAI | No action indicated | Biowave Corporation | 0 |
| 2010-07-28 | VAI | Voluntary action indicated | Biowave Corporation | 2 |
| 2010-07-28 | VAI | Voluntary action indicated | Biowave Corporation | 2 |
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