Skip to content
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.

65 linked reportsInjury 63Malfunction 2
23562019-01: 3 reports for this device; peer average 2.38/device2019-02: 1 reports for this device; peer average 2.17/device2019-03: 1 reports for this device; peer average 2.44/device2019-04: 0 reports for this device; peer average 2.41/device2019-05: 1 reports for this device; peer average 1.91/device2019-06: 0 reports for this device; peer average 1.68/device2019-07: 1 reports for this device; peer average 1.62/device2019-08: 0 reports for this device; peer average 2/device2019-09: 1 reports for this device; peer average 1.95/device2019-10: 3 reports for this device; peer average 2.18/device2019-11: 0 reports for this device; peer average 2.02/device2019-12: 4 reports for this device; peer average 2.22/device2020-01: 0 reports for this device; peer average 2.6/device2020-02: 2 reports for this device; peer average 2.2/device2020-03: 2 reports for this device; peer average 2.76/device2020-04: 0 reports for this device; peer average 2.1/device2020-05: 0 reports for this device; peer average 1.96/device2020-06: 0 reports for this device; peer average 1.9/device2020-07: 2 reports for this device; peer average 2.35/device2020-08: 4 reports for this device; peer average 1.97/device2020-09: 4 reports for this device; peer average 2.43/device2020-10: 2 reports for this device; peer average 2.38/device2020-11: 0 reports for this device; peer average 2.11/device2020-12: 2 reports for this device; peer average 2.16/device2021-01: 2 reports for this device; peer average 2.24/device2021-02: 2 reports for this device; peer average 1.96/device2021-03: 2 reports for this device; peer average 1.94/device2021-04: 0 reports for this device; peer average 1.96/device2021-05: 0 reports for this device; peer average 1.97/device2021-06: 2 reports for this device; peer average 2.23/device2021-07: 2 reports for this device; peer average 2.25/device2021-08: 0 reports for this device; peer average 2.21/device2021-09: 6 reports for this device; peer average 2.45/device2021-10: 0 reports for this device; peer average 2.19/device2021-11: 2 reports for this device; peer average 1.98/device2021-12: 2 reports for this device; peer average 2.12/device2022-01: 0 reports for this device; peer average 2.01/device2022-02: 0 reports for this device; peer average 2.06/device2022-03: 0 reports for this device; peer average 2.07/device2022-04: 0 reports for this device; peer average 2.05/device2022-05: 0 reports for this device; peer average 2.19/device2022-06: 0 reports for this device; peer average 2.09/device2022-07: 2 reports for this device; peer average 2.05/device2022-08: 0 reports for this device; peer average 2.11/device2022-09: 0 reports for this device; peer average 2.2/device2022-10: 2 reports for this device; peer average 2.13/device2022-11: 0 reports for this device; peer average 2.22/device2022-12: 2 reports for this device; peer average 2.07/device2023-01: 0 reports for this device; peer average 2.26/device2023-02: 0 reports for this device; peer average 2.08/device2023-03: 0 reports for this device; peer average 2.19/device2023-04: 0 reports for this device; peer average 2.24/device2023-05: 0 reports for this device; peer average 2.13/device2023-06: 0 reports for this device; peer average 2.26/device2023-07: 0 reports for this device; peer average 2.16/device2023-08: 0 reports for this device; peer average 1.92/device2023-09: 0 reports for this device; peer average 1.97/device2023-10: 0 reports for this device; peer average 1.67/device2023-11: 0 reports for this device; peer average 1.64/device2023-12: 0 reports for this device; peer average 1.74/device2024-01: 1 reports for this device; peer average 1.72/device2024-02: 0 reports for this device; peer average 2.06/device2024-03: 0 reports for this device; peer average 1.97/device2024-04: 0 reports for this device; peer average 1.82/device2024-05: 0 reports for this device; peer average 2.22/device2024-06: 0 reports for this device; peer average 1.97/device2024-07: 1 reports for this device; peer average 1.71/device2024-08: 0 reports for this device; peer average 2.03/device2024-09: 0 reports for this device; peer average 1.97/device2024-10: 0 reports for this device; peer average 1.81/device2024-11: 0 reports for this device; peer average 1.79/device2024-12: 0 reports for this device; peer average 1.62/device2025-01: 0 reports for this device; peer average 1.99/device2025-02: 2 reports for this device; peer average 1.58/device2025-03: 2 reports for this device; peer average 1.8/device2025-04: 0 reports for this device; peer average 1.84/device2025-05: 0 reports for this device; peer average 1.78/device2025-06: 0 reports for this device; peer average 1.87/device2025-07: 0 reports for this device; peer average 1.81/device2025-08: 0 reports for this device; peer average 1.78/device2025-09: 0 reports for this device; peer average 1.67/device2025-10: 0 reports for this device; peer average 1.72/device2025-11: 0 reports for this device; peer average 1.8/device2025-12: 0 reports for this device; peer average 1.92/device2026-01: 0 reports for this device; peer average 1.92/device2026-02: 0 reports for this device; peer average 1.72/device2026-03: 0 reports for this device; peer average 1.95/device2026-04: 0 reports for this device; peer average 1.97/device2026-05: 0 reports for this device; peer average 1.76/device2026-06: 0 reports for this device; peer average 1.8/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0132.38
2019-0212.17
2019-0312.44
2019-0402.41
2019-0511.91
2019-0601.68
2019-0711.62
2019-0802
2019-0911.95
2019-1032.18
2019-1102.02
2019-1242.22
2020-0102.6
2020-0222.2
2020-0322.76
2020-0402.1
2020-0501.96
2020-0601.9
2020-0722.35
2020-0841.97
2020-0942.43
2020-1022.38
2020-1102.11
2020-1222.16
2021-0122.24
2021-0221.96
2021-0321.94
2021-0401.96
2021-0501.97
2021-0622.23
2021-0722.25
2021-0802.21
2021-0962.45
2021-1002.19
2021-1121.98
2021-1222.12
2022-0102.01
2022-0202.06
2022-0302.07
2022-0402.05
2022-0502.19
2022-0602.09
2022-0722.05
2022-0802.11
2022-0902.2
2022-1022.13
2022-1102.22
2022-1222.07
2023-0102.26
2023-0202.08
2023-0302.19
2023-0402.24
2023-0502.13
2023-0602.26
2023-0702.16
2023-0801.92
2023-0901.97
2023-1001.67
2023-1101.64
2023-1201.74
2024-0111.72
2024-0202.06
2024-0301.97
2024-0401.82
2024-0502.22
2024-0601.97
2024-0711.71
2024-0802.03
2024-0901.97
2024-1001.81
2024-1101.79
2024-1201.62
2025-0101.99
2025-0221.58
2025-0321.8
2025-0401.84
2025-0501.78
2025-0601.87
2025-0701.81
2025-0801.78
2025-0901.67
2025-1001.72
2025-1101.8
2025-1201.92
2026-0101.92
2026-0201.72
2026-0301.95
2026-0401.97
2026-0501.76
2026-0601.8
This device (reports/month)Average device in LZO, 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
2025-03-313005180920-2025-00247InjuryAvailableexact di
2025-02-053005180920-2025-00004InjuryAvailableexact di
2024-07-163005180920-2024-00534InjuryAvailableexact di
2024-01-093005180920-2023-01085InjuryAvailableexact di
2022-12-283005180920-2022-00986InjuryAvailableexact di
2022-10-053005180920-2022-00754InjuryAvailableexact di
2022-07-063005180920-2022-00505InjuryAvailableexact di
2021-12-223005180920-2021-01030InjuryAvailableexact di
2021-11-243005180920-2021-00908InjuryAvailableexact di
2021-09-293005180920-2021-00779InjuryAvailableexact di
2021-09-153005180920-2021-00749InjuryAvailableexact di
2021-09-063005180920-2021-00720InjuryAvailableexact di
2021-07-093005180920-2021-00574InjuryAvailableexact di
2021-06-073005180920-2021-00484InjuryAvailableexact di
2021-03-083005180920-2021-00175InjuryAvailableexact di

Showing the most recent 39 of 65 linked reports.

Showing 1–15 of 39
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
    Similar devices
    Select up to two to place side-by-side with this device.