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.
4 linked reportsMalfunction 4
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-02 | 2 | 2 |
| 2019-12 | 2 | 2 |
| 2021-08 | 0 | 1 |
| 2021-11 | 0 | 2 |
| 2023-08 | 0 | 1 |
| 2023-11 | 0 | 1 |
| 2024-03 | 0 | 1 |
| 2024-05 | 0 | 1 |
| 2024-07 | 0 | 1 |
| 2024-08 | 0 | 1 |
| 2024-09 | 0 | 1 |
| 2024-10 | 0 | 1.5 |
| 2024-11 | 0 | 1 |
| 2025-01 | 0 | 1 |
| 2025-02 | 0 | 1 |
| 2025-03 | 0 | 1.5 |
| 2025-05 | 0 | 1.5 |
| 2025-07 | 0 | 1.5 |
| 2025-08 | 0 | 1.33 |
| 2025-09 | 0 | 1 |
| 2025-10 | 0 | 1.6 |
| 2025-12 | 0 | 1.67 |
| 2026-03 | 0 | 3 |
| 2026-05 | 0 | 3 |
Failure-mode summaryAI-generated
4 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2019-12-18 | 1060680-2019-00012 | Malfunction | Available | exact di |
| 2019-02-07 | 1060680-2019-00001 | Malfunction | Available | exact di |
Showing the most recent 2 of 4 linked reports.
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2025-01-07 | NAI | No action indicated | DeRoyal Industries Inc. | 0 |
| 2025-01-07 | NAI | No action indicated | DeRoyal Industries Inc. | 0 |
| 2019-10-01 | VAI | Voluntary action indicated | Deroyal Industries Inc | 1 |
| 2018-03-08 | NAI | No action indicated | DeRoyal Industries Inc. | 0 |
| 2017-12-08 | NAI | No action indicated | DeRoyal Industries Inc | 0 |
| 2017-12-08 | NAI | No action indicated | DeRoyal Industries Inc | 0 |
| 2017-12-06 | NAI | No action indicated | DeRoyal Industries Inc. | 0 |
| 2017-12-06 | NAI | No action indicated | DeRoyal Industries Inc. | 0 |
| 2017-07-27 | NAI | No action indicated | DeRoyal Industries, Inc. | 0 |
| 2017-07-27 | NAI | No action indicated | DeRoyal Industries, Inc. | 0 |
| 2017-07-25 | NAI | No action indicated | DeRoyal Industries Inc | 0 |
| 2017-07-25 | NAI | No action indicated | DeRoyal Industries Inc | 0 |
| 2017-03-13 | NAI | No action indicated | DeRoyal Industries, Inc. | 0 |
| 2017-03-13 | NAI | No action indicated | DeRoyal Industries, Inc. | 0 |
| 2016-11-17 | VAI | Voluntary action indicated | DEROYAL INDUSTRIES, INC. | 1 |
| 2016-11-17 | VAI | Voluntary action indicated | DEROYAL INDUSTRIES, INC. | 1 |
| 2015-05-19 | NAI | No action indicated | Deroyal Industries Inc | 0 |
| 2015-03-27 | VAI | Voluntary action indicated | DeRoyal Industries Inc | 3 |
| 2015-03-27 | VAI | Voluntary action indicated | DeRoyal Industries Inc | 3 |
| 2014-08-11 | VAI | Voluntary action indicated | DeRoyal Industries Inc | 0 |
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