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.
3 linked reportsInjury 3
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2020-09 | 0 | 1 |
| 2020-11 | 0 | 2 |
| 2021-01 | 0 | 1 |
| 2022-01 | 0 | 1 |
| 2022-04 | 0 | 1 |
| 2022-11 | 0 | 3 |
| 2023-03 | 0 | 3 |
| 2023-04 | 0 | 1 |
| 2023-09 | 0 | 1 |
| 2023-11 | 0 | 3 |
| 2024-05 | 0 | 2 |
| 2024-10 | 0 | 2 |
| 2024-12 | 0 | 2 |
| 2025-06 | 3 | 3 |
| 2025-09 | 0 | 4 |
| 2025-12 | 0 | 2 |
| 2026-02 | 0 | 2 |
| 2026-03 | 0 | 1 |
| 2026-04 | 0 | 2.33 |
| 2026-05 | 0 | 2 |
Failure-mode summaryAI-generated
3 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-06-13 | 2126670-2025-00001 | Injury | Available | catalog number |
Showing the most recent 1 of 3 linked reports.
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2019-08-15 | NAI | No action indicated | Scanlan International, Inc. | 0 |
| 2019-08-15 | NAI | No action indicated | Scanlan International, Inc. | 0 |
| 2016-02-03 | NAI | No action indicated | Scanlan International, Inc. | 0 |
| 2016-02-03 | NAI | No action indicated | Scanlan International, Inc. | 0 |
| 2012-10-17 | NAI | No action indicated | Scanlan International, Inc. | 0 |
| 2012-10-17 | NAI | No action indicated | Scanlan International, Inc. | 0 |
| 2010-06-22 | NAI | No action indicated | Scanlan International, Inc. | 0 |
| 2010-06-22 | NAI | No action indicated | Scanlan International, Inc. | 0 |