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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.

1,414 linked reportsMalfunction 1,312Injury 102
521051572092019-01: 0 reports for this device; peer average 6.09/device2019-02: 0 reports for this device; peer average 5.59/device2019-03: 0 reports for this device; peer average 6.19/device2019-04: 0 reports for this device; peer average 7.81/device2019-05: 0 reports for this device; peer average 6.19/device2019-06: 0 reports for this device; peer average 4/device2019-07: 0 reports for this device; peer average 6.26/device2019-08: 0 reports for this device; peer average 7.14/device2019-09: 0 reports for this device; peer average 8.45/device2019-10: 0 reports for this device; peer average 6.87/device2019-11: 0 reports for this device; peer average 8.74/device2019-12: 0 reports for this device; peer average 7.84/device2020-01: 0 reports for this device; peer average 7.88/device2020-02: 0 reports for this device; peer average 5.09/device2020-03: 0 reports for this device; peer average 11.85/device2020-04: 0 reports for this device; peer average 10.61/device2020-05: 0 reports for this device; peer average 8.36/device2020-06: 0 reports for this device; peer average 6.16/device2020-07: 0 reports for this device; peer average 7.48/device2020-08: 0 reports for this device; peer average 8.52/device2020-09: 0 reports for this device; peer average 7.38/device2020-10: 0 reports for this device; peer average 10/device2020-11: 0 reports for this device; peer average 11.68/device2020-12: 0 reports for this device; peer average 11.65/device2021-01: 0 reports for this device; peer average 15.59/device2021-02: 0 reports for this device; peer average 13.16/device2021-03: 0 reports for this device; peer average 9.9/device2021-04: 0 reports for this device; peer average 11.75/device2021-05: 0 reports for this device; peer average 9.33/device2021-06: 0 reports for this device; peer average 7.84/device2021-07: 0 reports for this device; peer average 12.05/device2021-08: 0 reports for this device; peer average 9.17/device2021-09: 0 reports for this device; peer average 9.29/device2021-10: 0 reports for this device; peer average 11.68/device2021-11: 0 reports for this device; peer average 9.78/device2021-12: 0 reports for this device; peer average 10/device2022-01: 0 reports for this device; peer average 7.76/device2022-02: 0 reports for this device; peer average 11.54/device2022-03: 0 reports for this device; peer average 10.67/device2022-04: 0 reports for this device; peer average 6.19/device2022-05: 3 reports for this device; peer average 8.31/device2022-06: 0 reports for this device; peer average 7.57/device2022-07: 3 reports for this device; peer average 6.16/device2022-08: 4 reports for this device; peer average 8.39/device2022-09: 1 reports for this device; peer average 6.64/device2022-10: 5 reports for this device; peer average 8.06/device2022-11: 20 reports for this device; peer average 11.06/device2022-12: 9 reports for this device; peer average 8.96/device2023-01: 18 reports for this device; peer average 11.86/device2023-02: 23 reports for this device; peer average 12.58/device2023-03: 22 reports for this device; peer average 14.73/device2023-04: 24 reports for this device; peer average 14.78/device2023-05: 22 reports for this device; peer average 13.18/device2023-06: 22 reports for this device; peer average 16.77/device2023-07: 31 reports for this device; peer average 17.81/device2023-08: 37 reports for this device; peer average 20.46/device2023-09: 18 reports for this device; peer average 13.43/device2023-10: 23 reports for this device; peer average 16.51/device2023-11: 9 reports for this device; peer average 9.24/device2023-12: 27 reports for this device; peer average 15.57/device2024-01: 15 reports for this device; peer average 10.25/device2024-02: 35 reports for this device; peer average 16.66/device2024-03: 82 reports for this device; peer average 40.35/device2024-04: 188 reports for this device; peer average 61.7/device2024-05: 209 reports for this device; peer average 72.31/device2024-06: 208 reports for this device; peer average 69.97/device2024-07: 168 reports for this device; peer average 55.17/device2024-08: 65 reports for this device; peer average 32.98/device2024-09: 54 reports for this device; peer average 28.96/device2024-10: 26 reports for this device; peer average 17.14/device2024-11: 20 reports for this device; peer average 15.37/device2024-12: 8 reports for this device; peer average 10.96/device2025-01: 1 reports for this device; peer average 8.77/device2025-02: 1 reports for this device; peer average 7.59/device2025-03: 2 reports for this device; peer average 7.76/device2025-04: 2 reports for this device; peer average 10.04/device2025-05: 0 reports for this device; peer average 12.83/device2025-06: 0 reports for this device; peer average 13.22/device2025-07: 1 reports for this device; peer average 7.86/device2025-08: 2 reports for this device; peer average 7.7/device2025-09: 1 reports for this device; peer average 7/device2025-10: 1 reports for this device; peer average 7.05/device2025-11: 0 reports for this device; peer average 16.97/device2025-12: 1 reports for this device; peer average 8.75/device2026-01: 1 reports for this device; peer average 8.62/device2026-02: 0 reports for this device; peer average 18.97/device2026-03: 1 reports for this device; peer average 8.78/device2026-04: 0 reports for this device; peer average 11.63/device2026-05: 1 reports for this device; peer average 11.57/device2026-06: 0 reports for this device; peer average 14.08/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0106.09
2019-0205.59
2019-0306.19
2019-0407.81
2019-0506.19
2019-0604
2019-0706.26
2019-0807.14
2019-0908.45
2019-1006.87
2019-1108.74
2019-1207.84
2020-0107.88
2020-0205.09
2020-03011.85
2020-04010.61
2020-0508.36
2020-0606.16
2020-0707.48
2020-0808.52
2020-0907.38
2020-10010
2020-11011.68
2020-12011.65
2021-01015.59
2021-02013.16
2021-0309.9
2021-04011.75
2021-0509.33
2021-0607.84
2021-07012.05
2021-0809.17
2021-0909.29
2021-10011.68
2021-1109.78
2021-12010
2022-0107.76
2022-02011.54
2022-03010.67
2022-0406.19
2022-0538.31
2022-0607.57
2022-0736.16
2022-0848.39
2022-0916.64
2022-1058.06
2022-112011.06
2022-1298.96
2023-011811.86
2023-022312.58
2023-032214.73
2023-042414.78
2023-052213.18
2023-062216.77
2023-073117.81
2023-083720.46
2023-091813.43
2023-102316.51
2023-1199.24
2023-122715.57
2024-011510.25
2024-023516.66
2024-038240.35
2024-0418861.7
2024-0520972.31
2024-0620869.97
2024-0716855.17
2024-086532.98
2024-095428.96
2024-102617.14
2024-112015.37
2024-12810.96
2025-0118.77
2025-0217.59
2025-0327.76
2025-04210.04
2025-05012.83
2025-06013.22
2025-0717.86
2025-0827.7
2025-0917
2025-1017.05
2025-11016.97
2025-1218.75
2026-0118.62
2026-02018.97
2026-0318.78
2026-04011.63
2026-05111.57
2026-06014.08
This device (reports/month)Average device in GAT (reports/device/month)
Failure-mode summaryAI-generated

40 linked report narratives available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2026-05-211028232-2026-02475InjuryAvailableexact di
2026-03-251028232-2026-01517InjuryAvailableexact di
2026-01-071028232-2026-00074MalfunctionAvailableexact di
2025-12-111645337-2025-13770InjuryAvailableexact di
2025-10-301645337-2025-11879InjuryAvailableexact di
2025-09-193008737795-2025-00025InjuryAvailableexact di
2025-08-201028232-2025-04091InjuryAvailableexact di
2025-08-111028232-2025-03890MalfunctionAvailableexact di
2025-07-081028232-2025-03232MalfunctionAvailableexact di
2025-04-291028232-2025-02087MalfunctionAvailableexact di
2025-04-031028232-2025-01630InjuryAvailableexact di
2025-03-181028232-2025-01367MalfunctionAvailableexact di
2025-03-111028232-2025-01244InjuryAvailableexact di
2025-02-201645337-2025-01719InjuryAvailableexact di
2025-01-231028232-2025-00372MalfunctionAvailableexact di

Showing the most recent 200 of 1,414 linked reports.

Showing 1–15 of 200
Regulatory clearances

    Predicate lineage

    K041894

    Cited as predicate by: K094028, K130467

    Cited as predicate by: K141711

    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
    DateTypeOutcomeFacilityCitations
    2014-05-12NAINo action indicatedC P Medical, Inc.0
    2010-09-22NAINo action indicatedC P Medical, Inc.0
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