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.
5 linked reportsMalfunction 4Injury 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-04 | 0 | 1 |
| 2020-02 | 0 | 1 |
| 2021-05 | 1 | 1 |
| 2021-08 | 0 | 1.67 |
| 2021-09 | 0 | 1 |
| 2021-10 | 0 | 1 |
| 2021-11 | 0 | 2 |
| 2021-12 | 0 | 8 |
| 2022-02 | 0 | 2 |
| 2022-03 | 0 | 1 |
| 2022-08 | 0 | 1 |
| 2022-09 | 0 | 1 |
| 2022-10 | 0 | 1 |
| 2023-02 | 1 | 1 |
| 2023-07 | 0 | 1 |
| 2023-12 | 1 | 1 |
| 2024-01 | 0 | 1 |
| 2025-01 | 1 | 1 |
| 2025-03 | 0 | 2 |
| 2025-05 | 0 | 1 |
| 2025-08 | 1 | 1 |
| 2025-09 | 0 | 1 |
| 2026-02 | 0 | 1 |
| 2026-04 | 0 | 1.8 |
| 2026-05 | 0 | 7.25 |
| 2026-06 | 0 | 4.8 |
Failure-mode summaryAI-generated
5 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-08-20 | 9681684-2025-00080 | Malfunction | Available | exact di |
| 2025-01-15 | 9681684-2025-00007 | Malfunction | Available | exact di |
| 2023-12-19 | 9681684-2023-00085 | Malfunction | Available | exact di |
| 2023-02-01 | 9681684-2023-00006 | Malfunction | Available | exact di |
| 2021-05-24 | 9681684-2021-00027 | Injury | Available | exact di |
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2015-04-23 | NAI | No action indicated | Arjo (Suzhou) Co., Ltd. | 0 |
| 2014-03-20 | VAI | Voluntary action indicated | ARJOHUNTLEIGH POLSKA Sp. z.o.o. | 3 |
| 2013-02-07 | NAI | No action indicated | ARJOHUNTLEIGH AB | 0 |
| 2013-02-07 | NAI | No action indicated | ARJOHUNTLEIGH AB | 0 |
| 2012-09-06 | VAI | Voluntary action indicated | Huntleigh Healthcare Ltd. | 0 |
| 2011-11-24 | NAI | No action indicated | Arjo (Suzhou) Co., Ltd. | 0 |
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