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 reportsMalfunction 2
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2023-07 | 0 | 1 |
| 2024-01 | 0 | 1 |
| 2024-02 | 0 | 1.5 |
| 2024-08 | 0 | 1.25 |
| 2024-09 | 0 | 2.5 |
| 2024-12 | 0 | 1.13 |
| 2025-01 | 0 | 2 |
| 2025-07 | 0 | 1.25 |
| 2025-10 | 0 | 1.5 |
| 2025-12 | 2 | 2.8 |
| 2026-01 | 0 | 1.5 |
| 2026-03 | 0 | 1.5 |
| 2026-04 | 0 | 1.5 |
| 2026-05 | 0 | 1.6 |
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 |
|---|---|---|---|---|
| 2025-12-22 | 9680353-2025-00054 | Malfunction | Available | catalog number |
Showing the most recent 1 of 2 linked reports.
Regulatory clearances
None linked.
Manufacturer compliance record
None in the loaded window.
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