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.
38 linked reportsInjury 22Malfunction 15Death 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 3.15 |
| 2019-02 | 0 | 2.5 |
| 2019-03 | 0 | 5.48 |
| 2019-04 | 0 | 16.27 |
| 2019-05 | 0 | 3.61 |
| 2019-06 | 0 | 2.9 |
| 2019-07 | 0 | 2.56 |
| 2019-08 | 0 | 3.75 |
| 2019-09 | 0 | 2.5 |
| 2019-10 | 0 | 2.37 |
| 2019-11 | 0 | 2.18 |
| 2019-12 | 0 | 4.71 |
| 2020-01 | 0 | 2.5 |
| 2020-02 | 0 | 4.32 |
| 2020-03 | 0 | 2.27 |
| 2020-04 | 0 | 4.19 |
| 2020-05 | 0 | 2.58 |
| 2020-06 | 0 | 3.62 |
| 2020-07 | 0 | 3.35 |
| 2020-08 | 0 | 2.91 |
| 2020-09 | 0 | 2.95 |
| 2020-10 | 0 | 3.19 |
| 2020-11 | 0 | 3.67 |
| 2020-12 | 0 | 4.92 |
| 2021-01 | 0 | 3.4 |
| 2021-02 | 0 | 3.04 |
| 2021-03 | 0 | 4.43 |
| 2021-04 | 0 | 3.89 |
| 2021-05 | 0 | 4.53 |
| 2021-06 | 0 | 4.19 |
| 2021-07 | 0 | 3.18 |
| 2021-08 | 0 | 4 |
| 2021-09 | 0 | 3.48 |
| 2021-10 | 0 | 3.84 |
| 2021-11 | 2 | 3.48 |
| 2021-12 | 0 | 4.14 |
| 2022-01 | 0 | 4.11 |
| 2022-02 | 0 | 4 |
| 2022-03 | 0 | 5.42 |
| 2022-04 | 0 | 5.5 |
| 2022-05 | 0 | 5.16 |
| 2022-06 | 3 | 4.75 |
| 2022-07 | 5 | 5.57 |
| 2022-08 | 1 | 4.8 |
| 2022-09 | 2 | 4.56 |
| 2022-10 | 0 | 5 |
| 2022-11 | 0 | 4.97 |
| 2022-12 | 0 | 4.89 |
| 2023-01 | 0 | 6.88 |
| 2023-02 | 2 | 4.82 |
| 2023-03 | 2 | 6.39 |
| 2023-04 | 0 | 5.47 |
| 2023-05 | 0 | 5.6 |
| 2023-06 | 0 | 6.44 |
| 2023-07 | 0 | 5.21 |
| 2023-08 | 3 | 6.32 |
| 2023-09 | 3 | 5.97 |
| 2023-10 | 0 | 6.56 |
| 2023-11 | 0 | 6.24 |
| 2023-12 | 0 | 6.12 |
| 2024-01 | 0 | 5.8 |
| 2024-02 | 0 | 5.32 |
| 2024-03 | 0 | 6.14 |
| 2024-04 | 0 | 5.33 |
| 2024-05 | 3 | 5.3 |
| 2024-06 | 0 | 6.54 |
| 2024-07 | 2 | 5.29 |
| 2024-08 | 0 | 6.8 |
| 2024-09 | 2 | 6.15 |
| 2024-10 | 2 | 6.67 |
| 2024-11 | 2 | 8.77 |
| 2024-12 | 0 | 3.63 |
| 2025-01 | 0 | 3.43 |
| 2025-02 | 3 | 3.08 |
| 2025-03 | 0 | 3.36 |
| 2025-04 | 0 | 3.7 |
| 2025-05 | 0 | 4.57 |
| 2025-06 | 0 | 4.17 |
| 2025-07 | 0 | 4.7 |
| 2025-08 | 0 | 4.3 |
| 2025-09 | 0 | 3.83 |
| 2025-10 | 0 | 4.58 |
| 2025-11 | 0 | 5.2 |
| 2025-12 | 0 | 8.42 |
| 2026-01 | 0 | 7.63 |
| 2026-02 | 0 | 5.27 |
| 2026-03 | 0 | 5.85 |
| 2026-04 | 0 | 7.26 |
| 2026-05 | 0 | 7.81 |
| 2026-06 | 1 | 6.19 |
Failure-mode summaryAI-generated
38 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-06-26 | 3014447948-2026-00030 | Injury | Available | exact di |
| 2025-02-11 | 3014447948-2025-00003 | Injury | Available | exact di |
| 2025-02-07 | 3014447948-2025-00002 | Death | Available | exact di |
| 2024-11-21 | 3014447948-2024-00025 | Malfunction | Available | exact di |
| 2024-10-25 | 3014447948-2024-00023 | Malfunction | Available | exact di |
| 2024-09-13 | 3014447948-2024-00019 | Malfunction | Available | exact di |
| 2024-07-09 | 3014447948-2024-00015 | Injury | Available | exact di |
| 2024-05-08 | 3014447948-2024-00011 | Injury | Available | model number |
| 2024-05-06 | 3014447948-2024-00009 | Injury | Available | exact di |
| 2023-09-07 | 3014447948-2023-00021 | Injury | Available | exact di |
| 2023-09-05 | 3014447948-2023-00020 | Injury | Available | exact di |
| 2023-08-24 | 3014447948-2023-00018 | Injury | Available | exact di |
| 2023-08-03 | 3014447948-2023-00014 | Injury | Available | exact di |
| 2023-03-14 | 3014447948-2023-00011 | Malfunction | Available | exact di |
| 2023-02-23 | 3014447948-2023-00005 | Malfunction | Available | exact di |
Showing the most recent 24 of 38 linked reports.
Showing 1–15 of 24
Regulatory clearances
Predicate lineage
- K173760
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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