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.
432 linked reportsMalfunction 429Injury 3
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.38 |
| 2019-02 | 0 | 3.51 |
| 2019-03 | 0 | 2.91 |
| 2019-04 | 0 | 3.08 |
| 2019-05 | 2 | 2.4 |
| 2019-06 | 4 | 3.5 |
| 2019-07 | 4 | 2.43 |
| 2019-08 | 4 | 2.43 |
| 2019-09 | 2 | 2.47 |
| 2019-10 | 13 | 2.79 |
| 2019-11 | 12 | 2.22 |
| 2019-12 | 2 | 2.35 |
| 2020-01 | 6 | 2.61 |
| 2020-02 | 0 | 2.68 |
| 2020-03 | 1 | 2.29 |
| 2020-04 | 0 | 2.49 |
| 2020-05 | 0 | 2.09 |
| 2020-06 | 3 | 2.76 |
| 2020-07 | 2 | 2.73 |
| 2020-08 | 3 | 4.28 |
| 2020-09 | 0 | 4.35 |
| 2020-10 | 9 | 3.98 |
| 2020-11 | 0 | 4.36 |
| 2020-12 | 1 | 3.77 |
| 2021-01 | 0 | 3.97 |
| 2021-02 | 2 | 3.87 |
| 2021-03 | 0 | 4.82 |
| 2021-04 | 0 | 4.64 |
| 2021-05 | 2 | 4.01 |
| 2021-06 | 3 | 4.27 |
| 2021-07 | 0 | 3.81 |
| 2021-08 | 0 | 3.86 |
| 2021-09 | 1 | 3.87 |
| 2021-10 | 1 | 3.94 |
| 2021-11 | 1 | 3.38 |
| 2021-12 | 2 | 4.36 |
| 2022-01 | 0 | 4.56 |
| 2022-02 | 1 | 4.94 |
| 2022-03 | 1 | 5.49 |
| 2022-04 | 1 | 6.29 |
| 2022-05 | 0 | 5.57 |
| 2022-06 | 2 | 5.99 |
| 2022-07 | 0 | 6.26 |
| 2022-08 | 1 | 6.25 |
| 2022-09 | 1 | 5.56 |
| 2022-10 | 2 | 5.39 |
| 2022-11 | 1 | 5.47 |
| 2022-12 | 3 | 6.03 |
| 2023-01 | 1 | 5.68 |
| 2023-02 | 1 | 4.81 |
| 2023-03 | 2 | 5.73 |
| 2023-04 | 0 | 5.38 |
| 2023-05 | 0 | 5.81 |
| 2023-06 | 0 | 6.94 |
| 2023-07 | 5 | 6.1 |
| 2023-08 | 10 | 6.31 |
| 2023-09 | 8 | 5.98 |
| 2023-10 | 8 | 6.34 |
| 2023-11 | 16 | 5.83 |
| 2023-12 | 2 | 5.92 |
| 2024-01 | 5 | 5.6 |
| 2024-02 | 4 | 6.09 |
| 2024-03 | 7 | 5.56 |
| 2024-04 | 4 | 6.33 |
| 2024-05 | 1 | 5.23 |
| 2024-06 | 5 | 7.01 |
| 2024-07 | 8 | 5.8 |
| 2024-08 | 9 | 6.6 |
| 2024-09 | 3 | 6.24 |
| 2024-10 | 4 | 6.99 |
| 2024-11 | 1 | 4.46 |
| 2024-12 | 7 | 4.75 |
| 2025-01 | 12 | 4.4 |
| 2025-02 | 12 | 4.09 |
| 2025-03 | 16 | 5.2 |
| 2025-04 | 4 | 4.69 |
| 2025-05 | 17 | 4.83 |
| 2025-06 | 15 | 4.6 |
| 2025-07 | 20 | 4.85 |
| 2025-08 | 22 | 5.61 |
| 2025-09 | 13 | 4.05 |
| 2025-10 | 7 | 4.56 |
| 2025-11 | 15 | 4.9 |
| 2025-12 | 3 | 5.97 |
| 2026-01 | 16 | 4.91 |
| 2026-02 | 14 | 4.99 |
| 2026-03 | 13 | 5.89 |
| 2026-04 | 17 | 6.26 |
| 2026-05 | 4 | 5.71 |
| 2026-06 | 8 | 4.91 |
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 |
|---|---|---|---|---|
| 2026-06-29 | 1221934-2026-02821 | Malfunction | — | catalog number |
| 2026-06-29 | 1221934-2026-02809 | Malfunction | — | catalog number |
| 2026-06-10 | 1221934-2026-02486 | Malfunction | Available | catalog number |
| 2026-06-04 | 1221934-2026-02398 | Malfunction | Available | catalog number |
| 2026-05-29 | 1221934-2026-02327 | Malfunction | Available | exact di |
| 2026-05-27 | 1221934-2026-02234 | Malfunction | Available | exact di |
| 2026-05-12 | 1221934-2026-02000 | Malfunction | Available | catalog number |
| 2026-04-28 | 1221934-2026-01720 | Malfunction | Available | catalog number |
| 2026-04-28 | 1221934-2026-01725 | Malfunction | Available | catalog number |
| 2026-04-23 | 1221934-2026-01627 | Malfunction | Available | exact di |
| 2026-04-21 | 1221934-2026-01584 | Malfunction | Available | catalog number |
| 2026-04-15 | 1221934-2026-01516 | Malfunction | Available | catalog number |
| 2026-04-11 | 1221934-2026-01486 | Malfunction | Available | catalog number |
| 2026-04-08 | 1221934-2026-01414 | Malfunction | Available | catalog number |
| 2026-04-08 | 1221934-2026-01420 | Malfunction | Available | catalog number |
Showing the most recent 200 of 432 linked reports.
Showing 1–15 of 200
Regulatory clearances
- 510(k)K123359Substantially equivalent (SESE) · 2012-12-19clearance family
Predicate lineage
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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