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.
14 linked reportsMalfunction 9Injury 5
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2022-09 | 3 | 2.5 |
| 2023-03 | 3 | 2.5 |
| 2024-01 | 3 | 2.5 |
| 2024-10 | 1 | 1 |
| 2026-01 | 2 | 2 |
| 2026-03 | 2 | 2 |
Failure-mode summaryAI-generated
14 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-03-25 | 24686535 | Malfunction | Available | catalog number |
| 2026-01-14 | 24066689 | Malfunction | Available | catalog number |
| 2024-10-01 | 3014447948-2024-00021 | Malfunction | Available | model number |
| 2024-01-29 | 3014447948-2023-00035 | Injury | Available | exact di |
| 2024-01-26 | MW5150830 | Malfunction | Available | model number |
| 2023-03-08 | 3014447948-2023-00010 | Malfunction | Available | catalog number |
| 2022-09-07 | 3014447948-2022-00028 | Injury | Available | catalog number |
Showing the most recent 7 of 14 linked reports.
Regulatory clearances
- 510(k)K203614Substantially equivalent (SESE) · 2021-03-11clearance family
Predicate lineage
- K203614
Cited as predicate by: K231473
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2020-02-07 | NAI | No action indicated | Auris Health Inc. | 0 |
| 2020-02-06 | NAI | No action indicated | AURIS HEALTH INC | 0 |
| 2020-02-06 | NAI | No action indicated | AURIS HEALTH INC | 0 |
| 2017-07-11 | NAI | No action indicated | Auris Health Inc. | 0 |
| 2017-02-13 | NAI | No action indicated | Auris Health Inc. | 0 |
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