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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.

84 linked reportsInjury 84
23562019-01: 0 reports for this device; peer average 1.76/device2019-02: 0 reports for this device; peer average 1.61/device2019-03: 1 reports for this device; peer average 1.73/device2019-04: 0 reports for this device; peer average 1.93/device2019-05: 0 reports for this device; peer average 1.6/device2019-06: 0 reports for this device; peer average 1.3/device2019-07: 1 reports for this device; peer average 1.4/device2019-08: 0 reports for this device; peer average 1.61/device2019-09: 0 reports for this device; peer average 1.47/device2019-10: 1 reports for this device; peer average 1.57/device2019-11: 0 reports for this device; peer average 1.66/device2019-12: 0 reports for this device; peer average 1.55/device2020-01: 2 reports for this device; peer average 1.57/device2020-02: 0 reports for this device; peer average 1.55/device2020-03: 0 reports for this device; peer average 1.84/device2020-04: 4 reports for this device; peer average 1.52/device2020-05: 1 reports for this device; peer average 1.32/device2020-06: 2 reports for this device; peer average 1.45/device2020-07: 0 reports for this device; peer average 1.72/device2020-08: 4 reports for this device; peer average 1.48/device2020-09: 0 reports for this device; peer average 1.61/device2020-10: 4 reports for this device; peer average 1.61/device2020-11: 0 reports for this device; peer average 1.48/device2020-12: 0 reports for this device; peer average 1.56/device2021-01: 4 reports for this device; peer average 1.54/device2021-02: 2 reports for this device; peer average 1.43/device2021-03: 0 reports for this device; peer average 1.46/device2021-04: 0 reports for this device; peer average 1.53/device2021-05: 2 reports for this device; peer average 1.53/device2021-06: 0 reports for this device; peer average 1.6/device2021-07: 0 reports for this device; peer average 1.46/device2021-08: 0 reports for this device; peer average 1.39/device2021-09: 0 reports for this device; peer average 1.84/device2021-10: 4 reports for this device; peer average 1.51/device2021-11: 0 reports for this device; peer average 1.5/device2021-12: 4 reports for this device; peer average 1.4/device2022-01: 0 reports for this device; peer average 1.37/device2022-02: 0 reports for this device; peer average 1.47/device2022-03: 0 reports for this device; peer average 1.44/device2022-04: 2 reports for this device; peer average 1.41/device2022-05: 0 reports for this device; peer average 1.64/device2022-06: 0 reports for this device; peer average 1.55/device2022-07: 0 reports for this device; peer average 1.44/device2022-08: 0 reports for this device; peer average 1.65/device2022-09: 2 reports for this device; peer average 1.67/device2022-10: 0 reports for this device; peer average 1.59/device2022-11: 0 reports for this device; peer average 1.68/device2022-12: 2 reports for this device; peer average 1.37/device2023-01: 0 reports for this device; peer average 1.35/device2023-02: 2 reports for this device; peer average 1.48/device2023-03: 0 reports for this device; peer average 1.64/device2023-04: 0 reports for this device; peer average 1.79/device2023-05: 2 reports for this device; peer average 1.68/device2023-06: 0 reports for this device; peer average 1.9/device2023-07: 1 reports for this device; peer average 1.9/device2023-08: 1 reports for this device; peer average 1.71/device2023-09: 3 reports for this device; peer average 1.82/device2023-10: 0 reports for this device; peer average 1.42/device2023-11: 0 reports for this device; peer average 1.36/device2023-12: 0 reports for this device; peer average 1.4/device2024-01: 0 reports for this device; peer average 1.47/device2024-02: 0 reports for this device; peer average 1.67/device2024-03: 0 reports for this device; peer average 1.88/device2024-04: 2 reports for this device; peer average 1.63/device2024-05: 0 reports for this device; peer average 2.19/device2024-06: 0 reports for this device; peer average 1.9/device2024-07: 0 reports for this device; peer average 1.51/device2024-08: 0 reports for this device; peer average 1.99/device2024-09: 1 reports for this device; peer average 1.82/device2024-10: 0 reports for this device; peer average 1.66/device2024-11: 0 reports for this device; peer average 1.39/device2024-12: 1 reports for this device; peer average 1.45/device2025-01: 0 reports for this device; peer average 1.64/device2025-02: 2 reports for this device; peer average 1.43/device2025-03: 2 reports for this device; peer average 1.71/device2025-04: 4 reports for this device; peer average 1.65/device2025-05: 2 reports for this device; peer average 1.44/device2025-06: 2 reports for this device; peer average 1.66/device2025-07: 2 reports for this device; peer average 1.59/device2025-08: 0 reports for this device; peer average 1.44/device2025-09: 0 reports for this device; peer average 1.48/device2025-10: 1 reports for this device; peer average 1.47/device2025-11: 2 reports for this device; peer average 1.59/device2025-12: 6 reports for this device; peer average 1.76/device2026-01: 0 reports for this device; peer average 1.61/device2026-02: 0 reports for this device; peer average 1.46/device2026-03: 2 reports for this device; peer average 1.87/device2026-04: 0 reports for this device; peer average 1.67/device2026-05: 0 reports for this device; peer average 1.46/device2026-06: 4 reports for this device; peer average 1.61/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.76
2019-0201.61
2019-0311.73
2019-0401.93
2019-0501.6
2019-0601.3
2019-0711.4
2019-0801.61
2019-0901.47
2019-1011.57
2019-1101.66
2019-1201.55
2020-0121.57
2020-0201.55
2020-0301.84
2020-0441.52
2020-0511.32
2020-0621.45
2020-0701.72
2020-0841.48
2020-0901.61
2020-1041.61
2020-1101.48
2020-1201.56
2021-0141.54
2021-0221.43
2021-0301.46
2021-0401.53
2021-0521.53
2021-0601.6
2021-0701.46
2021-0801.39
2021-0901.84
2021-1041.51
2021-1101.5
2021-1241.4
2022-0101.37
2022-0201.47
2022-0301.44
2022-0421.41
2022-0501.64
2022-0601.55
2022-0701.44
2022-0801.65
2022-0921.67
2022-1001.59
2022-1101.68
2022-1221.37
2023-0101.35
2023-0221.48
2023-0301.64
2023-0401.79
2023-0521.68
2023-0601.9
2023-0711.9
2023-0811.71
2023-0931.82
2023-1001.42
2023-1101.36
2023-1201.4
2024-0101.47
2024-0201.67
2024-0301.88
2024-0421.63
2024-0502.19
2024-0601.9
2024-0701.51
2024-0801.99
2024-0911.82
2024-1001.66
2024-1101.39
2024-1211.45
2025-0101.64
2025-0221.43
2025-0321.71
2025-0441.65
2025-0521.44
2025-0621.66
2025-0721.59
2025-0801.44
2025-0901.48
2025-1011.47
2025-1121.59
2025-1261.76
2026-0101.61
2026-0201.46
2026-0321.87
2026-0401.67
2026-0501.46
2026-0641.61
This device (reports/month)Average device in MEH (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
2026-06-303005180920-2026-00614InjuryAvailableexact di
2026-06-173005180920-2026-00580InjuryAvailableexact di
2026-03-133005180920-2026-00209InjuryAvailableexact di
2025-12-183005180920-2025-01254InjuryAvailableexact di
2025-12-183005180920-2025-01259InjuryAvailableexact di
2025-12-023005180920-2025-01207InjuryAvailableexact di
2025-11-053005180920-2025-01082InjuryAvailableexact di
2025-10-023005180920-2025-00948InjuryAvailablemodel number
2025-07-183005180920-2025-00695InjuryAvailableexact di
2025-06-063005180920-2025-00533InjuryAvailableexact di
2025-05-123005180920-2025-00397InjuryAvailableexact di
2025-04-303005180920-2025-00326InjuryAvailableexact di
2025-04-293005180920-2025-00337InjuryAvailableexact di
2025-03-283005180920-2025-00267InjuryAvailableexact di
2025-02-033005180920-2025-00024InjuryAvailableexact di

Showing the most recent 49 of 84 linked reports.

Showing 1–15 of 49
Regulatory clearances

    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
    DateTypeOutcomeFacilityCitations
    2024-11-19VAIVoluntary action indicatedMedacta International, SA1
    2024-11-19VAIVoluntary action indicatedMedacta International SA0
    2024-11-19VAIVoluntary action indicatedMedacta International, SA1
    2024-11-19VAIVoluntary action indicatedMedacta International SA0
    2017-06-19VAIVoluntary action indicatedMedacta International SA0
    2017-06-19VAIVoluntary action indicatedMedacta International SA0
    2017-02-17VAIVoluntary action indicatedParcus Medical, LLC2
    2015-02-05OAIOfficial action indicatedMedacta International SA8
    2015-02-05OAIOfficial action indicatedMedacta International SA8
    2013-08-16VAIVoluntary action indicatedParcus Medical, LLC1
    2010-01-28VAIVoluntary action indicatedMedacta International SA0
    2010-01-28VAIVoluntary action indicatedMedacta International SA0
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