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.
66 linked reportsMalfunction 63Injury 3
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 4 |
| 2019-02 | 0 | 1.25 |
| 2019-03 | 0 | 1.8 |
| 2019-04 | 0 | 2 |
| 2019-05 | 0 | 1.75 |
| 2019-06 | 0 | 1.5 |
| 2019-07 | 2 | 2.24 |
| 2019-08 | 0 | 1.89 |
| 2019-09 | 0 | 2.38 |
| 2019-10 | 0 | 2.46 |
| 2019-11 | 0 | 4.11 |
| 2019-12 | 0 | 3 |
| 2020-01 | 0 | 3 |
| 2020-02 | 0 | 5 |
| 2020-03 | 0 | 2.85 |
| 2020-04 | 0 | 4.25 |
| 2020-05 | 0 | 2.5 |
| 2020-06 | 0 | 2.75 |
| 2020-07 | 0 | 2.38 |
| 2020-08 | 0 | 2.82 |
| 2020-09 | 0 | 3.14 |
| 2020-10 | 0 | 1.25 |
| 2020-11 | 0 | 5 |
| 2020-12 | 0 | 1.22 |
| 2021-01 | 0 | 1.8 |
| 2021-02 | 0 | 5 |
| 2021-03 | 0 | 2.38 |
| 2021-04 | 0 | 1.9 |
| 2021-05 | 0 | 2.13 |
| 2021-06 | 0 | 2.25 |
| 2021-07 | 0 | 2 |
| 2021-08 | 0 | 2.8 |
| 2021-09 | 0 | 1.86 |
| 2021-10 | 0 | 1.33 |
| 2021-11 | 0 | 3.33 |
| 2021-12 | 0 | 2.67 |
| 2022-01 | 1 | 2.36 |
| 2022-02 | 0 | 1.25 |
| 2022-03 | 1 | 2 |
| 2022-04 | 0 | 1.77 |
| 2022-05 | 0 | 1.75 |
| 2022-06 | 1 | 2 |
| 2022-07 | 0 | 2.1 |
| 2022-08 | 0 | 3.57 |
| 2022-09 | 1 | 2.11 |
| 2022-10 | 1 | 2.1 |
| 2022-11 | 0 | 2.4 |
| 2022-12 | 0 | 1.43 |
| 2023-01 | 0 | 2.14 |
| 2023-02 | 0 | 1.3 |
| 2023-03 | 0 | 2.38 |
| 2023-04 | 0 | 1.7 |
| 2023-05 | 0 | 1.25 |
| 2023-06 | 0 | 1.29 |
| 2023-07 | 1 | 1.57 |
| 2023-08 | 0 | 3.2 |
| 2023-09 | 3 | 1.71 |
| 2023-10 | 0 | 1.45 |
| 2023-11 | 0 | 3 |
| 2023-12 | 1 | 1 |
| 2024-01 | 1 | 1.25 |
| 2024-02 | 1 | 1.44 |
| 2024-03 | 2 | 1.43 |
| 2024-04 | 1 | 1 |
| 2024-05 | 0 | 1 |
| 2024-06 | 0 | 1.4 |
| 2024-07 | 2 | 1.4 |
| 2024-08 | 0 | 1.33 |
| 2024-09 | 0 | 1.67 |
| 2024-10 | 2 | 2.17 |
| 2024-11 | 1 | 2 |
| 2024-12 | 2 | 2.5 |
| 2025-01 | 1 | 1.43 |
| 2025-02 | 2 | 1.33 |
| 2025-03 | 3 | 1.3 |
| 2025-04 | 3 | 1.86 |
| 2025-05 | 2 | 1.64 |
| 2025-07 | 5 | 2 |
| 2025-08 | 2 | 1.67 |
| 2025-09 | 0 | 2.2 |
| 2025-10 | 0 | 1.33 |
| 2025-11 | 3 | 1.89 |
| 2025-12 | 0 | 3.17 |
| 2026-01 | 1 | 3 |
| 2026-02 | 3 | 3 |
| 2026-03 | 6 | 2.08 |
| 2026-04 | 4 | 2.57 |
| 2026-05 | 5 | 3.17 |
| 2026-06 | 2 | 2.71 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-06-25 | 1528319-2026-00073 | Malfunction | — | exact di |
| 2026-06-05 | 1528319-2026-00064 | Malfunction | Available | exact di |
| 2026-05-21 | 1528319-2026-00053 | Malfunction | Available | catalog number |
| 2026-05-15 | 1528319-2026-00051 | Malfunction | Available | exact di |
| 2026-05-07 | 1528319-2026-00047 | Malfunction | Available | exact di |
| 2026-04-22 | 1528319-2026-00035 | Malfunction | Available | catalog number |
| 2026-04-01 | 1528319-2026-00026 | Malfunction | Available | exact di |
| 2026-03-30 | 1528319-2026-00025 | Malfunction | Available | exact di |
| 2026-03-25 | 1528319-2026-00024 | Malfunction | Available | exact di |
| 2026-03-19 | 1528319-2026-00023 | Malfunction | Available | exact di |
| 2026-03-12 | 1528319-2026-00021 | Malfunction | Available | catalog number |
| 2026-02-26 | 1528319-2026-00017 | Malfunction | Available | catalog number |
| 2026-01-29 | 1528319-2026-00005 | Malfunction | Available | exact di |
| 2025-11-17 | 1528319-2025-00105 | Malfunction | Available | catalog number |
| 2025-08-27 | 1528319-2025-00088 | Malfunction | Available | catalog number |
Showing the most recent 48 of 66 linked reports.
Showing 1–15 of 48
Regulatory clearances
- 510(k)K223369Substantially equivalent (SESE) · 2022-12-02clearance family
- 510(k)K222272Substantially equivalent (SESE) · 2022-08-18clearance family
- 510(k)K171626Substantially equivalent (SESE) · 2017-08-30clearance family
Predicate lineage
- K171626
- K222272
Cited as predicate by: K223369
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
None in the loaded window.
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