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.
8 linked reportsInjury 8
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-05 | 0 | 1 |
| 2021-06 | 0 | 1 |
| 2022-02 | 0 | 1 |
| 2022-03 | 0 | 2 |
| 2022-04 | 0 | 1 |
| 2022-08 | 0 | 2 |
| 2022-09 | 0 | 2 |
| 2023-01 | 0 | 2 |
| 2023-09 | 0 | 2 |
| 2024-02 | 0 | 3 |
| 2024-05 | 0 | 1 |
| 2024-07 | 0 | 2 |
| 2024-08 | 0 | 1 |
| 2024-09 | 0 | 2 |
| 2024-10 | 0 | 2 |
| 2024-11 | 0 | 3.33 |
| 2025-01 | 0 | 1.67 |
| 2025-04 | 0 | 2.67 |
| 2025-06 | 0 | 3 |
| 2025-09 | 0 | 2 |
| 2025-10 | 0 | 9 |
| 2025-12 | 0 | 4 |
| 2026-02 | 0 | 1.5 |
| 2026-04 | 8 | 5 |
| 2026-05 | 0 | 2.5 |
| 2026-06 | 0 | 2 |
Failure-mode summaryAI-generated
8 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-04-23 | 1220828-2026-00009 | Injury | Available | catalog number |
| 2026-04-23 | 9610691-2026-00008 | Injury | Available | catalog number |
| 2026-04-23 | 1220828-2026-00008 | Injury | Available | exact di |
| 2026-04-23 | 9610691-2026-00009 | Injury | Available | catalog number |
Showing the most recent 4 of 8 linked reports.
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2016-05-20 | VAI | Voluntary action indicated | AMBU Limited | 0 |
| 2016-04-15 | VAI | Voluntary action indicated | Ambu Sdn. Bhd. | 0 |
| 2013-11-07 | VAI | Voluntary action indicated | AMBU Limited | 2 |
| 2013-09-19 | VAI | Voluntary action indicated | Ambu Sdn. Bhd. | 5 |
| 2013-06-19 | NAI | No action indicated | Ambu A/S | 0 |
| 2013-06-19 | NAI | No action indicated | Ambu A/S | 0 |
| 2011-06-02 | VAI | Voluntary action indicated | AMBU Limited | 2 |
| 2010-02-09 | NAI | No action indicated | Ambu A/S | 0 |
| 2010-02-09 | NAI | No action indicated | Ambu A/S | 0 |
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