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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.

24 linked reportsInjury 18Malfunction 6
12232019-01: 0 reports for this device; peer average 2.99/device2019-02: 1 reports for this device; peer average 2.54/device2019-03: 1 reports for this device; peer average 2.81/device2019-04: 0 reports for this device; peer average 2.7/device2019-05: 0 reports for this device; peer average 2.12/device2019-06: 2 reports for this device; peer average 1.87/device2019-07: 0 reports for this device; peer average 1.86/device2019-08: 0 reports for this device; peer average 2.15/device2019-09: 0 reports for this device; peer average 2.29/device2019-10: 0 reports for this device; peer average 2.48/device2019-11: 0 reports for this device; peer average 2.09/device2019-12: 1 reports for this device; peer average 2.45/device2020-01: 0 reports for this device; peer average 2.88/device2020-02: 0 reports for this device; peer average 2.53/device2020-03: 0 reports for this device; peer average 3.24/device2020-04: 0 reports for this device; peer average 2.27/device2020-05: 2 reports for this device; peer average 2.31/device2020-06: 0 reports for this device; peer average 2.02/device2020-07: 0 reports for this device; peer average 2.56/device2020-08: 0 reports for this device; peer average 2.07/device2020-09: 0 reports for this device; peer average 2.57/device2020-10: 2 reports for this device; peer average 2.62/device2020-11: 2 reports for this device; peer average 2.28/device2020-12: 0 reports for this device; peer average 2.34/device2021-01: 0 reports for this device; peer average 2.39/device2021-02: 2 reports for this device; peer average 2.11/device2021-03: 0 reports for this device; peer average 2.1/device2021-04: 2 reports for this device; peer average 2.04/device2021-05: 0 reports for this device; peer average 2.08/device2021-06: 0 reports for this device; peer average 2.43/device2021-07: 0 reports for this device; peer average 2.4/device2021-08: 0 reports for this device; peer average 2.26/device2021-09: 0 reports for this device; peer average 2.47/device2021-10: 0 reports for this device; peer average 2.25/device2021-11: 0 reports for this device; peer average 2.16/device2021-12: 0 reports for this device; peer average 2.39/device2022-01: 0 reports for this device; peer average 2.12/device2022-02: 0 reports for this device; peer average 2.33/device2022-03: 2 reports for this device; peer average 2.16/device2022-04: 0 reports for this device; peer average 2.23/device2022-05: 0 reports for this device; peer average 2.22/device2022-06: 0 reports for this device; peer average 2.2/device2022-07: 2 reports for this device; peer average 2.16/device2022-08: 0 reports for this device; peer average 2.22/device2022-09: 0 reports for this device; peer average 2.23/device2022-10: 0 reports for this device; peer average 2.21/device2022-11: 0 reports for this device; peer average 2.32/device2022-12: 0 reports for this device; peer average 2.28/device2023-01: 0 reports for this device; peer average 2.24/device2023-02: 0 reports for this device; peer average 2.14/device2023-03: 0 reports for this device; peer average 2.27/device2023-04: 0 reports for this device; peer average 2.23/device2023-05: 0 reports for this device; peer average 2.24/device2023-06: 0 reports for this device; peer average 2.3/device2023-07: 0 reports for this device; peer average 2.2/device2023-08: 0 reports for this device; peer average 2.02/device2023-09: 1 reports for this device; peer average 2.04/device2023-10: 0 reports for this device; peer average 1.68/device2023-11: 0 reports for this device; peer average 1.68/device2023-12: 0 reports for this device; peer average 1.76/device2024-01: 0 reports for this device; peer average 1.76/device2024-02: 0 reports for this device; peer average 2.06/device2024-03: 0 reports for this device; peer average 1.99/device2024-04: 0 reports for this device; peer average 1.8/device2024-05: 0 reports for this device; peer average 2.2/device2024-06: 0 reports for this device; peer average 1.95/device2024-07: 0 reports for this device; peer average 1.76/device2024-08: 0 reports for this device; peer average 1.95/device2024-09: 0 reports for this device; peer average 2.01/device2024-10: 0 reports for this device; peer average 1.76/device2024-11: 0 reports for this device; peer average 1.79/device2024-12: 2 reports for this device; peer average 1.62/device2025-01: 0 reports for this device; peer average 1.95/device2025-02: 0 reports for this device; peer average 1.56/device2025-03: 0 reports for this device; peer average 1.75/device2025-04: 0 reports for this device; peer average 1.85/device2025-05: 0 reports for this device; peer average 1.73/device2025-06: 0 reports for this device; peer average 1.86/device2025-07: 2 reports for this device; peer average 1.81/device2025-08: 0 reports for this device; peer average 1.77/device2025-09: 0 reports for this device; peer average 1.76/device2025-10: 0 reports for this device; peer average 1.77/device2025-11: 0 reports for this device; peer average 1.89/device2025-12: 0 reports for this device; peer average 1.94/device2026-01: 0 reports for this device; peer average 2.03/device2026-02: 0 reports for this device; peer average 1.71/device2026-03: 0 reports for this device; peer average 2.05/device2026-04: 0 reports for this device; peer average 1.98/device2026-05: 0 reports for this device; peer average 1.88/device2026-06: 0 reports for this device; peer average 1.79/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.99
2019-0212.54
2019-0312.81
2019-0402.7
2019-0502.12
2019-0621.87
2019-0701.86
2019-0802.15
2019-0902.29
2019-1002.48
2019-1102.09
2019-1212.45
2020-0102.88
2020-0202.53
2020-0303.24
2020-0402.27
2020-0522.31
2020-0602.02
2020-0702.56
2020-0802.07
2020-0902.57
2020-1022.62
2020-1122.28
2020-1202.34
2021-0102.39
2021-0222.11
2021-0302.1
2021-0422.04
2021-0502.08
2021-0602.43
2021-0702.4
2021-0802.26
2021-0902.47
2021-1002.25
2021-1102.16
2021-1202.39
2022-0102.12
2022-0202.33
2022-0322.16
2022-0402.23
2022-0502.22
2022-0602.2
2022-0722.16
2022-0802.22
2022-0902.23
2022-1002.21
2022-1102.32
2022-1202.28
2023-0102.24
2023-0202.14
2023-0302.27
2023-0402.23
2023-0502.24
2023-0602.3
2023-0702.2
2023-0802.02
2023-0912.04
2023-1001.68
2023-1101.68
2023-1201.76
2024-0101.76
2024-0202.06
2024-0301.99
2024-0401.8
2024-0502.2
2024-0601.95
2024-0701.76
2024-0801.95
2024-0902.01
2024-1001.76
2024-1101.79
2024-1221.62
2025-0101.95
2025-0201.56
2025-0301.75
2025-0401.85
2025-0501.73
2025-0601.86
2025-0721.81
2025-0801.77
2025-0901.76
2025-1001.77
2025-1101.89
2025-1201.94
2026-0102.03
2026-0201.71
2026-0302.05
2026-0401.98
2026-0501.88
2026-0601.79
This device (reports/month)Average device in JDI, LZO (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2025-07-173005180920-2025-00682MalfunctionAvailableexact di
2024-12-093005180920-2024-01061InjuryAvailableexact di
2023-09-203005180920-2023-00708InjuryAvailableexact di
2022-07-063005180920-2022-00521InjuryAvailableexact di
2022-03-313005180920-2022-00215InjuryAvailableexact di
2021-04-273005180920-2021-00347InjuryAvailableexact di
2021-02-033005180920-2021-00076InjuryAvailableexact di
2020-11-113005180920-2020-00796InjuryAvailableexact di
2020-10-093005180920-2020-00693InjuryAvailableexact di
2020-05-073005180920-2020-00272InjuryAvailableexact di
2019-12-193005180920-2019-01087InjuryAvailableexact di
2019-06-183005180920-2019-00477MalfunctionAvailableexact di
2019-03-133005180920-2019-00150MalfunctionAvailableexact di
2019-02-083005180920-2019-00039MalfunctionAvailableexact di

Showing the most recent 14 of 24 linked reports.

Regulatory clearances

    Predicate lineage

    Cited as predicate by: K112115, K122911, K161635, K173794, K193433

    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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