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.
729 linked reportsMalfunction 724Injury 5
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 4.67 |
| 2019-02 | 0 | 2.34 |
| 2019-03 | 0 | 3.13 |
| 2019-04 | 0 | 3.17 |
| 2019-05 | 0 | 3.26 |
| 2019-06 | 0 | 2.82 |
| 2019-07 | 0 | 3.81 |
| 2019-08 | 0 | 3.49 |
| 2019-09 | 0 | 3.35 |
| 2019-10 | 0 | 3.19 |
| 2019-11 | 0 | 5.28 |
| 2019-12 | 2 | 5.45 |
| 2020-01 | 3 | 5.46 |
| 2020-02 | 0 | 4.5 |
| 2020-03 | 0 | 3.98 |
| 2020-04 | 0 | 5.42 |
| 2020-05 | 0 | 3.88 |
| 2020-06 | 3 | 3.71 |
| 2020-07 | 0 | 3.74 |
| 2020-08 | 9 | 4.23 |
| 2020-09 | 9 | 4.05 |
| 2020-10 | 9 | 4.53 |
| 2020-11 | 31 | 6.39 |
| 2020-12 | 15 | 5.41 |
| 2021-01 | 0 | 4.74 |
| 2021-02 | 3 | 3.95 |
| 2021-03 | 1 | 3.83 |
| 2021-04 | 1 | 3.82 |
| 2021-05 | 2 | 4.06 |
| 2021-06 | 1 | 4.11 |
| 2021-07 | 6 | 4 |
| 2021-08 | 6 | 4.46 |
| 2021-09 | 10 | 4.05 |
| 2021-10 | 13 | 4.44 |
| 2021-11 | 3 | 4.37 |
| 2021-12 | 9 | 4.43 |
| 2022-01 | 4 | 4 |
| 2022-02 | 5 | 3.37 |
| 2022-03 | 4 | 3.88 |
| 2022-04 | 3 | 3.8 |
| 2022-05 | 5 | 4.06 |
| 2022-06 | 4 | 3.85 |
| 2022-07 | 8 | 3.56 |
| 2022-08 | 7 | 4.39 |
| 2022-09 | 6 | 3.86 |
| 2022-10 | 6 | 4.15 |
| 2022-11 | 4 | 2.87 |
| 2022-12 | 6 | 3.93 |
| 2023-01 | 2 | 3.27 |
| 2023-02 | 4 | 3.2 |
| 2023-03 | 3 | 3.8 |
| 2023-04 | 7 | 4.26 |
| 2023-05 | 1 | 4.67 |
| 2023-06 | 5 | 4.2 |
| 2023-07 | 2 | 3.85 |
| 2023-08 | 8 | 4.49 |
| 2023-09 | 12 | 4.47 |
| 2023-10 | 6 | 4.71 |
| 2023-11 | 16 | 4.63 |
| 2023-12 | 13 | 5.49 |
| 2024-01 | 8 | 5.56 |
| 2024-02 | 9 | 4.93 |
| 2024-03 | 18 | 4.78 |
| 2024-04 | 4 | 5.43 |
| 2024-05 | 14 | 6.48 |
| 2024-06 | 9 | 7.52 |
| 2024-07 | 2 | 4.11 |
| 2024-08 | 9 | 4.21 |
| 2024-09 | 16 | 5 |
| 2024-10 | 29 | 4.7 |
| 2024-11 | 12 | 4.41 |
| 2024-12 | 14 | 4.25 |
| 2025-01 | 12 | 5.12 |
| 2025-02 | 12 | 4.81 |
| 2025-03 | 6 | 4.57 |
| 2025-04 | 26 | 4.98 |
| 2025-05 | 19 | 5.81 |
| 2025-06 | 25 | 5.47 |
| 2025-07 | 30 | 5.19 |
| 2025-08 | 11 | 5.08 |
| 2025-09 | 12 | 4.29 |
| 2025-10 | 24 | 4.62 |
| 2025-11 | 18 | 5.25 |
| 2025-12 | 10 | 6.07 |
| 2026-01 | 12 | 5.06 |
| 2026-02 | 17 | 5.39 |
| 2026-03 | 11 | 5.98 |
| 2026-04 | 15 | 5.93 |
| 2026-05 | 18 | 5.88 |
| 2026-06 | 30 | 6.16 |
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 |
|---|---|---|---|---|
| 2026-06-30 | 1221934-2026-02843 | Malfunction | — | catalog number |
| 2026-06-30 | 1221934-2026-02850 | Malfunction | — | exact di |
| 2026-06-30 | 1221934-2026-02844 | Malfunction | — | catalog number |
| 2026-06-25 | 1221934-2026-02764 | Malfunction | — | catalog number |
| 2026-06-25 | 1221934-2026-02784 | Malfunction | — | catalog number |
| 2026-06-24 | 1221934-2026-02775 | Malfunction | — | catalog number |
| 2026-06-23 | 1221934-2026-02751 | Malfunction | — | catalog number |
| 2026-06-18 | 1221934-2026-02653 | Malfunction | Available | catalog number |
| 2026-06-15 | 1221934-2026-02595 | Malfunction | Available | catalog number |
| 2026-06-11 | 1221934-2026-02505 | Malfunction | Available | catalog number |
| 2026-06-11 | 1221934-2026-02512 | Malfunction | Available | exact di |
| 2026-06-10 | 1221934-2026-02489 | Malfunction | Available | catalog number |
| 2026-06-10 | 1221934-2026-02488 | Malfunction | Available | catalog number |
| 2026-06-10 | 1221934-2026-02490 | Malfunction | Available | catalog number |
| 2026-06-10 | 1221934-2026-02491 | Malfunction | Available | catalog number |
Showing the most recent 200 of 729 linked reports.
Showing 1–15 of 200
Regulatory clearances
- 510(k)K153667Substantially equivalent (SESE) · 2016-03-24clearance family
Predicate lineage
Cited as predicate by: K233601
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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