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.
18 linked reportsMalfunction 16Injury 2
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-03 | 0 | 2 |
| 2019-05 | 0 | 1 |
| 2019-08 | 0 | 2 |
| 2019-09 | 0 | 1.5 |
| 2019-10 | 0 | 1.5 |
| 2019-12 | 0 | 2 |
| 2020-02 | 0 | 2 |
| 2020-03 | 0 | 1 |
| 2020-07 | 0 | 3 |
| 2020-08 | 0 | 2 |
| 2020-09 | 0 | 1.33 |
| 2020-10 | 0 | 2.5 |
| 2020-11 | 0 | 2 |
| 2020-12 | 0 | 1.67 |
| 2021-03 | 0 | 1 |
| 2021-04 | 0 | 5 |
| 2021-05 | 0 | 2 |
| 2021-06 | 0 | 2 |
| 2021-07 | 0 | 2 |
| 2021-08 | 0 | 1 |
| 2021-09 | 0 | 1 |
| 2021-11 | 0 | 1.57 |
| 2021-12 | 0 | 1 |
| 2022-01 | 0 | 1 |
| 2022-02 | 0 | 2 |
| 2022-04 | 0 | 1.5 |
| 2022-06 | 2 | 2 |
| 2022-08 | 0 | 5 |
| 2022-09 | 0 | 1 |
| 2022-10 | 0 | 1 |
| 2022-11 | 0 | 1.33 |
| 2022-12 | 0 | 2 |
| 2023-01 | 0 | 1 |
| 2023-02 | 0 | 2 |
| 2023-04 | 0 | 6 |
| 2023-05 | 0 | 4.67 |
| 2023-07 | 0 | 8 |
| 2023-08 | 0 | 1 |
| 2023-09 | 0 | 1 |
| 2023-10 | 0 | 2 |
| 2023-11 | 0 | 1 |
| 2024-01 | 0 | 2.33 |
| 2024-02 | 0 | 3.13 |
| 2024-03 | 6 | 4.25 |
| 2024-04 | 0 | 1.8 |
| 2024-05 | 1 | 1.28 |
| 2024-06 | 0 | 3 |
| 2024-07 | 0 | 2.33 |
| 2024-08 | 0 | 4 |
| 2024-09 | 0 | 2.25 |
| 2024-10 | 0 | 1.5 |
| 2024-11 | 0 | 1.33 |
| 2024-12 | 0 | 2 |
| 2025-01 | 0 | 2 |
| 2025-02 | 0 | 1 |
| 2025-03 | 0 | 1 |
| 2025-04 | 0 | 1 |
| 2025-06 | 0 | 2 |
| 2025-09 | 2 | 1.17 |
| 2025-12 | 0 | 2 |
| 2026-01 | 4 | 3 |
| 2026-03 | 0 | 1.5 |
| 2026-04 | 0 | 1.67 |
| 2026-05 | 0 | 2.44 |
| 2026-06 | 3 | 3 |
Failure-mode summaryAI-generated
18 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-06-16 | 2126670-2026-00003 | Malfunction | Available | catalog number |
| 2026-01-23 | 2126670-2026-00001 | Malfunction | Available | catalog number |
| 2026-01-12 | 24034547 | Malfunction | Available | catalog number |
| 2025-09-24 | 2126670-2025-00002 | Malfunction | Available | catalog number |
| 2024-05-14 | 2126670-2023-00001 | Malfunction | Available | model number |
| 2024-03-28 | 2126670-2024-00003 | Malfunction | Available | catalog number |
| 2024-03-28 | 2126670-2024-00002 | Malfunction | Available | catalog number |
| 2022-06-10 | MW5110251 | Injury | Available | catalog number |
Showing the most recent 8 of 18 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 |
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