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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.

15 linked reportsInjury 13Malfunction 2
12232019-01: 0 reports for this device; peer average 2.72/device2019-02: 0 reports for this device; peer average 2.45/device2019-03: 0 reports for this device; peer average 2.79/device2019-04: 0 reports for this device; peer average 2.65/device2019-05: 0 reports for this device; peer average 2.07/device2019-06: 0 reports for this device; peer average 1.85/device2019-07: 0 reports for this device; peer average 1.73/device2019-08: 0 reports for this device; peer average 2.19/device2019-09: 0 reports for this device; peer average 2.2/device2019-10: 0 reports for this device; peer average 2.5/device2019-11: 0 reports for this device; peer average 2.2/device2019-12: 0 reports for this device; peer average 2.55/device2020-01: 0 reports for this device; peer average 3.08/device2020-02: 0 reports for this device; peer average 2.52/device2020-03: 0 reports for this device; peer average 3.17/device2020-04: 0 reports for this device; peer average 2.37/device2020-05: 0 reports for this device; peer average 2.26/device2020-06: 0 reports for this device; peer average 2.13/device2020-07: 0 reports for this device; peer average 2.62/device2020-08: 0 reports for this device; peer average 2.21/device2020-09: 0 reports for this device; peer average 2.8/device2020-10: 0 reports for this device; peer average 2.76/device2020-11: 0 reports for this device; peer average 2.4/device2020-12: 0 reports for this device; peer average 2.47/device2021-01: 0 reports for this device; peer average 2.52/device2021-02: 0 reports for this device; peer average 2.24/device2021-03: 0 reports for this device; peer average 2.2/device2021-04: 0 reports for this device; peer average 2.17/device2021-05: 0 reports for this device; peer average 2.19/device2021-06: 0 reports for this device; peer average 2.49/device2021-07: 0 reports for this device; peer average 2.58/device2021-08: 0 reports for this device; peer average 2.56/device2021-09: 0 reports for this device; peer average 2.75/device2021-10: 0 reports for this device; peer average 2.46/device2021-11: 0 reports for this device; peer average 2.22/device2021-12: 0 reports for this device; peer average 2.46/device2022-01: 0 reports for this device; peer average 2.31/device2022-02: 0 reports for this device; peer average 2.33/device2022-03: 0 reports for this device; peer average 2.38/device2022-04: 0 reports for this device; peer average 2.3/device2022-05: 0 reports for this device; peer average 2.46/device2022-06: 0 reports for this device; peer average 2.32/device2022-07: 0 reports for this device; peer average 2.32/device2022-08: 0 reports for this device; peer average 2.33/device2022-09: 0 reports for this device; peer average 2.44/device2022-10: 2 reports for this device; peer average 2.4/device2022-11: 0 reports for this device; peer average 2.48/device2022-12: 0 reports for this device; peer average 2.48/device2023-01: 0 reports for this device; peer average 2.63/device2023-02: 0 reports for this device; peer average 2.34/device2023-03: 0 reports for this device; peer average 2.47/device2023-04: 0 reports for this device; peer average 2.44/device2023-05: 0 reports for this device; peer average 2.35/device2023-06: 0 reports for this device; peer average 2.45/device2023-07: 0 reports for this device; peer average 2.31/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 1.8/device2023-11: 2 reports for this device; peer average 1.78/device2023-12: 0 reports for this device; peer average 1.89/device2024-01: 0 reports for this device; peer average 1.84/device2024-02: 0 reports for this device; peer average 2.21/device2024-03: 0 reports for this device; peer average 2.01/device2024-04: 0 reports for this device; peer average 1.91/device2024-05: 0 reports for this device; peer average 2.24/device2024-06: 0 reports for this device; peer average 2/device2024-07: 0 reports for this device; peer average 1.82/device2024-08: 0 reports for this device; peer average 2.05/device2024-09: 0 reports for this device; peer average 2.05/device2024-10: 2 reports for this device; peer average 1.87/device2024-11: 0 reports for this device; peer average 1.99/device2024-12: 2 reports for this device; peer average 1.71/device2025-01: 0 reports for this device; peer average 2.18/device2025-02: 0 reports for this device; peer average 1.66/device2025-03: 0 reports for this device; peer average 1.85/device2025-04: 0 reports for this device; peer average 1.95/device2025-05: 0 reports for this device; peer average 1.94/device2025-06: 0 reports for this device; peer average 1.97/device2025-07: 0 reports for this device; peer average 1.92/device2025-08: 0 reports for this device; peer average 1.94/device2025-09: 2 reports for this device; peer average 1.75/device2025-10: 0 reports for this device; peer average 1.84/device2025-11: 0 reports for this device; peer average 1.9/device2025-12: 0 reports for this device; peer average 1.99/device2026-01: 0 reports for this device; peer average 2.04/device2026-02: 2 reports for this device; peer average 1.83/device2026-03: 0 reports for this device; peer average 1.98/device2026-04: 2 reports for this device; peer average 2.12/device2026-05: 0 reports for this device; peer average 1.92/device2026-06: 0 reports for this device; peer average 1.88/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.72
2019-0202.45
2019-0302.79
2019-0402.65
2019-0502.07
2019-0601.85
2019-0701.73
2019-0802.19
2019-0902.2
2019-1002.5
2019-1102.2
2019-1202.55
2020-0103.08
2020-0202.52
2020-0303.17
2020-0402.37
2020-0502.26
2020-0602.13
2020-0702.62
2020-0802.21
2020-0902.8
2020-1002.76
2020-1102.4
2020-1202.47
2021-0102.52
2021-0202.24
2021-0302.2
2021-0402.17
2021-0502.19
2021-0602.49
2021-0702.58
2021-0802.56
2021-0902.75
2021-1002.46
2021-1102.22
2021-1202.46
2022-0102.31
2022-0202.33
2022-0302.38
2022-0402.3
2022-0502.46
2022-0602.32
2022-0702.32
2022-0802.33
2022-0902.44
2022-1022.4
2022-1102.48
2022-1202.48
2023-0102.63
2023-0202.34
2023-0302.47
2023-0402.44
2023-0502.35
2023-0602.45
2023-0702.31
2023-0802.02
2023-0912.04
2023-1001.8
2023-1121.78
2023-1201.89
2024-0101.84
2024-0202.21
2024-0302.01
2024-0401.91
2024-0502.24
2024-0602
2024-0701.82
2024-0802.05
2024-0902.05
2024-1021.87
2024-1101.99
2024-1221.71
2025-0102.18
2025-0201.66
2025-0301.85
2025-0401.95
2025-0501.94
2025-0601.97
2025-0701.92
2025-0801.94
2025-0921.75
2025-1001.84
2025-1101.9
2025-1201.99
2026-0102.04
2026-0221.83
2026-0301.98
2026-0422.12
2026-0501.92
2026-0601.88
This device (reports/month)Average device in LZO (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2026-04-143005180920-2026-00315InjuryAvailableexact di
2026-02-123005180920-2026-00085InjuryAvailableexact di
2025-09-303005180920-2025-00918MalfunctionAvailableexact di
2024-12-303005180920-2024-01137InjuryAvailableexact di
2024-10-283005180920-2024-00864InjuryAvailableexact di
2023-11-223005180920-2023-00918InjuryAvailableexact di
2023-09-193005180920-2023-00737InjuryAvailableexact di
2022-10-203005180920-2022-00792InjuryAvailableexact di

Showing the most recent 8 of 15 linked reports.

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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