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) |
|---|---|---|
| 2019-04 | 0 | 1 |
| 2019-05 | 0 | 4 |
| 2019-10 | 0 | 2 |
| 2019-12 | 2 | 2 |
| 2020-01 | 0 | 1 |
| 2020-06 | 0 | 3 |
| 2020-09 | 0 | 1 |
| 2020-10 | 0 | 1 |
| 2020-12 | 0 | 2 |
| 2021-01 | 0 | 5.5 |
| 2021-05 | 0 | 1 |
| 2021-07 | 0 | 2 |
| 2021-08 | 0 | 3 |
| 2021-09 | 0 | 11 |
| 2021-10 | 0 | 1 |
| 2022-02 | 0 | 3 |
| 2022-03 | 0 | 1 |
| 2022-04 | 0 | 1 |
| 2022-06 | 0 | 3 |
| 2022-09 | 0 | 1 |
| 2023-02 | 0 | 3 |
| 2023-03 | 0 | 1 |
| 2023-05 | 0 | 1.5 |
| 2023-07 | 0 | 1 |
| 2023-09 | 0 | 1.5 |
| 2023-12 | 0 | 2 |
| 2024-02 | 0 | 1 |
| 2024-03 | 0 | 4 |
| 2024-04 | 0 | 2 |
| 2024-05 | 0 | 1.5 |
| 2024-07 | 0 | 2 |
| 2024-08 | 0 | 1.33 |
| 2024-09 | 0 | 1 |
| 2024-11 | 0 | 1 |
| 2025-01 | 0 | 3 |
| 2025-02 | 0 | 2 |
| 2025-03 | 0 | 1.5 |
| 2025-04 | 0 | 2 |
| 2025-06 | 0 | 2 |
| 2025-07 | 0 | 2 |
| 2025-08 | 0 | 2 |
| 2025-11 | 0 | 1 |
| 2026-02 | 0 | 2 |
| 2026-04 | 0 | 2 |
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 |
|---|---|---|---|---|
| 2019-12-13 | MW5091681 | Malfunction | Available | catalog number |
Showing the most recent 1 of 2 linked reports.
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2026-02-06 | NAI | No action indicated | Xodus Medical Inc | 0 |
| 2026-02-06 | NAI | No action indicated | Xodus Medical Inc | 0 |
| 2019-08-14 | VAI | Voluntary action indicated | Xodus Medical Inc | 7 |
| 2019-08-14 | VAI | Voluntary action indicated | Xodus Medical Inc | 7 |
| 2017-10-10 | NAI | No action indicated | Xodus Medical Inc | 0 |
| 2017-10-10 | NAI | No action indicated | Xodus Medical Inc | 0 |
| 2015-07-10 | NAI | No action indicated | Xodus Medical Inc | 0 |
| 2015-07-10 | NAI | No action indicated | Xodus Medical Inc | 0 |
| 2013-02-19 | VAI | Voluntary action indicated | Xodus Medical Inc | 2 |
| 2013-02-19 | VAI | Voluntary action indicated | Xodus Medical Inc | 2 |
| 2012-09-21 | NAI | No action indicated | Xodus Medical Inc | 0 |
| 2012-09-21 | NAI | No action indicated | Xodus Medical Inc | 0 |
| 2010-09-13 | NAI | No action indicated | Xodus Medical Inc | 0 |
| 2010-09-13 | NAI | No action indicated | Xodus Medical Inc | 0 |
Similar devices
- "108"" OR EXTENSION LEG STRAP BLACK" Bird & Cronin, LLC
- "120"" OR EXT. LEG STRAP BLACK" Bird & Cronin, LLC
- "2"" BLOCK ONLY FOR WEHBE PREP ASSIST" MIZUHO ORTHOPEDIC SYSTEMS, INC.
- "3"" BLOCK ONLY FOR WEHBE PREP ASSIST" MIZUHO ORTHOPEDIC SYSTEMS, INC.
- "9"" FOAM HEADREST W/PLUG" Bird & Cronin, LLC
- "90"" OR EXT. LEG STRAP BLACK" Bird & Cronin, LLC
- "ALISTRAP SOFT 1.5"" X 30'" ALIMED, INC.
- "ALISTRAP SOFT 2"" X 30'" ALIMED, INC.
- "Batrik Gel Bean Bag Postioner 40x30""" Batrik Medical Manufacturing Inc
- "Batrik NIMBUS Floor Mat 20""x32"" Taupe" Batrik Medical Manufacturing Inc
- "Batrik NIMBUS Floor Mat 20""x32"" Taupe" Batrik Medical Manufacturing Inc
- "Batrik NIMBUS Floor Mat 20""x48"" Taupe" Batrik Medical Manufacturing Inc
Select up to two to place side-by-side with this device.