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.
1 linked reportMalfunction 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 10.56 |
| 2019-02 | 0 | 12.69 |
| 2019-03 | 0 | 11.63 |
| 2019-04 | 1 | 12.46 |
| 2019-05 | 0 | 12.27 |
| 2019-06 | 0 | 10.34 |
| 2019-07 | 0 | 11.67 |
| 2019-08 | 0 | 16.27 |
| 2019-09 | 0 | 12.2 |
| 2019-10 | 0 | 13.33 |
| 2019-11 | 0 | 16.63 |
| 2019-12 | 0 | 20.13 |
| 2020-01 | 0 | 14.15 |
| 2020-02 | 0 | 18.53 |
| 2020-03 | 0 | 17.04 |
| 2020-04 | 0 | 19.1 |
| 2020-05 | 0 | 30.98 |
| 2020-06 | 0 | 17.15 |
| 2020-07 | 0 | 24.74 |
| 2020-08 | 0 | 28.38 |
| 2020-09 | 0 | 74.85 |
| 2020-10 | 0 | 99.6 |
| 2020-11 | 0 | 192.07 |
| 2020-12 | 0 | 385.31 |
| 2021-01 | 0 | 264.09 |
| 2021-02 | 0 | 106.71 |
| 2021-03 | 0 | 77.38 |
| 2021-04 | 0 | 78.29 |
| 2021-05 | 0 | 72.41 |
| 2021-06 | 0 | 74.45 |
| 2021-07 | 0 | 89.1 |
| 2021-08 | 0 | 111.07 |
| 2021-09 | 0 | 151.73 |
| 2021-10 | 0 | 318.48 |
| 2021-11 | 0 | 385.2 |
| 2021-12 | 0 | 1212.16 |
| 2022-01 | 0 | 2694.92 |
| 2022-02 | 0 | 1413.28 |
| 2022-03 | 0 | 2239.43 |
| 2022-04 | 0 | 2411.59 |
| 2022-05 | 0 | 1936.71 |
| 2022-06 | 0 | 1803.15 |
| 2022-07 | 0 | 888.18 |
| 2022-08 | 0 | 227.64 |
| 2022-09 | 0 | 287.35 |
| 2022-10 | 0 | 256.49 |
| 2022-11 | 0 | 245.91 |
| 2022-12 | 0 | 228.98 |
| 2023-01 | 0 | 127.34 |
| 2023-02 | 0 | 255.75 |
| 2023-03 | 0 | 305.05 |
| 2023-04 | 0 | 263.63 |
| 2023-05 | 0 | 240.84 |
| 2023-06 | 0 | 298.8 |
| 2023-07 | 0 | 281.34 |
| 2023-08 | 0 | 268.34 |
| 2023-09 | 0 | 219.98 |
| 2023-10 | 0 | 129.77 |
| 2023-11 | 0 | 130.95 |
| 2023-12 | 0 | 63.55 |
| 2024-01 | 0 | 67.35 |
| 2024-02 | 0 | 101.17 |
| 2024-03 | 0 | 71.21 |
| 2024-04 | 0 | 76.75 |
| 2024-05 | 0 | 46.49 |
| 2024-06 | 0 | 50.21 |
| 2024-07 | 0 | 45.53 |
| 2024-08 | 0 | 41.36 |
| 2024-09 | 0 | 48.22 |
| 2024-10 | 0 | 50.88 |
| 2024-11 | 0 | 57.8 |
| 2024-12 | 0 | 53.16 |
| 2025-01 | 0 | 64.36 |
| 2025-02 | 0 | 57.67 |
| 2025-03 | 0 | 83.62 |
| 2025-04 | 0 | 71.4 |
| 2025-05 | 0 | 81.16 |
| 2025-06 | 0 | 87.33 |
| 2025-07 | 0 | 119.88 |
| 2025-08 | 0 | 83.67 |
| 2025-09 | 0 | 81.89 |
| 2025-10 | 0 | 93.65 |
| 2025-11 | 0 | 83 |
| 2025-12 | 0 | 88.56 |
| 2026-01 | 0 | 74.52 |
| 2026-02 | 0 | 76.73 |
| 2026-03 | 0 | 87.13 |
| 2026-04 | 0 | 143.63 |
| 2026-05 | 0 | 327.5 |
| 2026-06 | 0 | 351.16 |
Failure-mode summaryAI-generated
1 linked report narrative available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2019-04-12 | 1219702-2019-00021 | Malfunction | Available | exact di |
Regulatory clearances
Predicate lineage
K091855
Cited as predicate by: K141654
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 |
|---|---|---|---|---|
| 2013-06-21 | VAI | Voluntary action indicated | Belmont Instrument LLC | 2 |
| 2013-06-21 | VAI | Voluntary action indicated | Belmont Instrument LLC | 2 |
| 2012-05-07 | WL | Warning Letter | Belmont Instrument LLC | — |
| 2012-05-07 | WL | Warning Letter | Belmont Instrument LLC | — |
| 2011-04-27 | VAI | Voluntary action indicated | Belmont Instrument LLC | 3 |
| 2011-04-27 | VAI | Voluntary action indicated | Belmont Instrument LLC | 3 |
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