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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.

131 linked reportsInjury 128Malfunction 3
24682019-01: 2 reports for this device; peer average 2.03/device2019-02: 0 reports for this device; peer average 2.07/device2019-03: 0 reports for this device; peer average 1.68/device2019-04: 0 reports for this device; peer average 2.01/device2019-05: 1 reports for this device; peer average 1.83/device2019-06: 1 reports for this device; peer average 2.19/device2019-07: 2 reports for this device; peer average 2.04/device2019-08: 0 reports for this device; peer average 2.24/device2019-09: 2 reports for this device; peer average 2.01/device2019-10: 0 reports for this device; peer average 2.44/device2019-11: 0 reports for this device; peer average 3.01/device2019-12: 1 reports for this device; peer average 2.42/device2020-01: 0 reports for this device; peer average 2.39/device2020-02: 2 reports for this device; peer average 2.82/device2020-03: 0 reports for this device; peer average 2.28/device2020-04: 0 reports for this device; peer average 2.21/device2020-05: 0 reports for this device; peer average 1.83/device2020-06: 0 reports for this device; peer average 2.09/device2020-07: 0 reports for this device; peer average 2.66/device2020-08: 2 reports for this device; peer average 2.72/device2020-09: 4 reports for this device; peer average 2.23/device2020-10: 0 reports for this device; peer average 2.94/device2020-11: 2 reports for this device; peer average 2.86/device2020-12: 0 reports for this device; peer average 2.95/device2021-01: 4 reports for this device; peer average 2.47/device2021-02: 0 reports for this device; peer average 2.45/device2021-03: 0 reports for this device; peer average 2.59/device2021-04: 2 reports for this device; peer average 2.45/device2021-05: 0 reports for this device; peer average 2.36/device2021-06: 0 reports for this device; peer average 2.18/device2021-07: 6 reports for this device; peer average 2.24/device2021-08: 2 reports for this device; peer average 1.88/device2021-09: 6 reports for this device; peer average 2.33/device2021-10: 4 reports for this device; peer average 1.96/device2021-11: 0 reports for this device; peer average 2.31/device2021-12: 2 reports for this device; peer average 2.33/device2022-01: 0 reports for this device; peer average 2.03/device2022-02: 0 reports for this device; peer average 2.38/device2022-03: 0 reports for this device; peer average 2.05/device2022-04: 6 reports for this device; peer average 2.1/device2022-05: 2 reports for this device; peer average 2.33/device2022-06: 0 reports for this device; peer average 2.03/device2022-07: 0 reports for this device; peer average 2.06/device2022-08: 0 reports for this device; peer average 2.1/device2022-09: 4 reports for this device; peer average 2.28/device2022-10: 8 reports for this device; peer average 2.2/device2022-11: 2 reports for this device; peer average 2.24/device2022-12: 2 reports for this device; peer average 1.9/device2023-01: 2 reports for this device; peer average 2.09/device2023-02: 6 reports for this device; peer average 2.23/device2023-03: 6 reports for this device; peer average 2.23/device2023-04: 0 reports for this device; peer average 2.26/device2023-05: 2 reports for this device; peer average 2.41/device2023-06: 4 reports for this device; peer average 2.26/device2023-07: 3 reports for this device; peer average 2/device2023-08: 2 reports for this device; peer average 1.71/device2023-09: 1 reports for this device; peer average 1.76/device2023-10: 3 reports for this device; peer average 1.63/device2023-11: 0 reports for this device; peer average 1.68/device2023-12: 1 reports for this device; peer average 1.7/device2024-01: 0 reports for this device; peer average 1.57/device2024-02: 0 reports for this device; peer average 1.74/device2024-03: 2 reports for this device; peer average 1.78/device2024-04: 1 reports for this device; peer average 1.64/device2024-05: 2 reports for this device; peer average 1.91/device2024-06: 0 reports for this device; peer average 1.98/device2024-07: 0 reports for this device; peer average 1.85/device2024-08: 0 reports for this device; peer average 2.31/device2024-09: 0 reports for this device; peer average 2/device2024-10: 0 reports for this device; peer average 1.99/device2024-11: 2 reports for this device; peer average 2/device2024-12: 2 reports for this device; peer average 2.09/device2025-01: 0 reports for this device; peer average 2.32/device2025-02: 5 reports for this device; peer average 1.83/device2025-03: 0 reports for this device; peer average 1.86/device2025-04: 0 reports for this device; peer average 1.66/device2025-05: 0 reports for this device; peer average 1.71/device2025-06: 2 reports for this device; peer average 1.81/device2025-07: 6 reports for this device; peer average 1.62/device2025-08: 0 reports for this device; peer average 1.63/device2025-09: 0 reports for this device; peer average 1.64/device2025-10: 0 reports for this device; peer average 1.43/device2025-11: 0 reports for this device; peer average 1.7/device2025-12: 0 reports for this device; peer average 1.66/device2026-01: 0 reports for this device; peer average 1.55/device2026-02: 2 reports for this device; peer average 1.53/device2026-03: 2 reports for this device; peer average 1.99/device2026-04: 2 reports for this device; peer average 1.75/device2026-05: 4 reports for this device; peer average 1.71/device2026-06: 0 reports for this device; peer average 1.7/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0122.03
2019-0202.07
2019-0301.68
2019-0402.01
2019-0511.83
2019-0612.19
2019-0722.04
2019-0802.24
2019-0922.01
2019-1002.44
2019-1103.01
2019-1212.42
2020-0102.39
2020-0222.82
2020-0302.28
2020-0402.21
2020-0501.83
2020-0602.09
2020-0702.66
2020-0822.72
2020-0942.23
2020-1002.94
2020-1122.86
2020-1202.95
2021-0142.47
2021-0202.45
2021-0302.59
2021-0422.45
2021-0502.36
2021-0602.18
2021-0762.24
2021-0821.88
2021-0962.33
2021-1041.96
2021-1102.31
2021-1222.33
2022-0102.03
2022-0202.38
2022-0302.05
2022-0462.1
2022-0522.33
2022-0602.03
2022-0702.06
2022-0802.1
2022-0942.28
2022-1082.2
2022-1122.24
2022-1221.9
2023-0122.09
2023-0262.23
2023-0362.23
2023-0402.26
2023-0522.41
2023-0642.26
2023-0732
2023-0821.71
2023-0911.76
2023-1031.63
2023-1101.68
2023-1211.7
2024-0101.57
2024-0201.74
2024-0321.78
2024-0411.64
2024-0521.91
2024-0601.98
2024-0701.85
2024-0802.31
2024-0902
2024-1001.99
2024-1122
2024-1222.09
2025-0102.32
2025-0251.83
2025-0301.86
2025-0401.66
2025-0501.71
2025-0621.81
2025-0761.62
2025-0801.63
2025-0901.64
2025-1001.43
2025-1101.7
2025-1201.66
2026-0101.55
2026-0221.53
2026-0321.99
2026-0421.75
2026-0541.71
2026-0601.7
This device (reports/month)Average device in JWH (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
2026-05-293005180920-2026-00512InjuryAvailableexact di
2026-05-123005180920-2026-00339InjuryAvailableexact di
2026-04-093005180920-2026-00283InjuryAvailableexact di
2026-03-103005180920-2026-00206InjuryAvailableexact di
2026-02-123005180920-2026-00102InjuryAvailableexact di
2025-07-253005180920-2025-00716InjuryAvailableexact di
2025-07-183005180920-2025-00677InjuryAvailableexact di
2025-07-023005180920-2025-00621InjuryAvailableexact di
2025-06-033005180920-2025-00481InjuryAvailableexact di
2025-02-283005180920-2025-00138InjuryAvailablemodel number
2025-02-113005180920-2025-00081InjuryAvailableexact di
2025-02-113005180920-2025-00090InjuryAvailableexact di
2024-12-033005180920-2024-01002InjuryAvailableexact di
2024-11-053005180920-2024-00923InjuryAvailableexact di
2024-05-243005180920-2024-00357InjuryAvailableexact di

Showing the most recent 77 of 131 linked reports.

Showing 1–15 of 77
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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