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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.

67 linked reportsMalfunction 55Injury 12
51015212019-01: 0 reports for this device; peer average 3.78/device2019-02: 0 reports for this device; peer average 2.69/device2019-03: 0 reports for this device; peer average 3.27/device2019-04: 0 reports for this device; peer average 4.36/device2019-05: 0 reports for this device; peer average 2.23/device2019-06: 0 reports for this device; peer average 4.77/device2019-07: 0 reports for this device; peer average 4.32/device2019-08: 0 reports for this device; peer average 3/device2019-09: 0 reports for this device; peer average 2.67/device2019-10: 0 reports for this device; peer average 3.18/device2019-11: 0 reports for this device; peer average 2.72/device2019-12: 0 reports for this device; peer average 3.65/device2020-01: 0 reports for this device; peer average 3/device2020-02: 0 reports for this device; peer average 3.67/device2020-03: 0 reports for this device; peer average 3.65/device2020-04: 0 reports for this device; peer average 3.17/device2020-05: 0 reports for this device; peer average 2.3/device2020-06: 0 reports for this device; peer average 5/device2020-07: 0 reports for this device; peer average 2.04/device2020-08: 0 reports for this device; peer average 2.5/device2020-09: 0 reports for this device; peer average 2.26/device2020-10: 0 reports for this device; peer average 3.5/device2020-11: 0 reports for this device; peer average 3.14/device2020-12: 0 reports for this device; peer average 4.21/device2021-01: 0 reports for this device; peer average 2.25/device2021-02: 0 reports for this device; peer average 4.5/device2021-03: 0 reports for this device; peer average 3.95/device2021-04: 0 reports for this device; peer average 3.53/device2021-05: 0 reports for this device; peer average 2.67/device2021-06: 2 reports for this device; peer average 7.33/device2021-07: 0 reports for this device; peer average 10.76/device2021-08: 0 reports for this device; peer average 5.43/device2021-09: 0 reports for this device; peer average 5.22/device2021-10: 0 reports for this device; peer average 7.62/device2021-11: 0 reports for this device; peer average 5.4/device2021-12: 2 reports for this device; peer average 6.65/device2022-01: 2 reports for this device; peer average 5.95/device2022-02: 0 reports for this device; peer average 3.39/device2022-03: 0 reports for this device; peer average 9.28/device2022-04: 0 reports for this device; peer average 4/device2022-05: 0 reports for this device; peer average 4.85/device2022-06: 0 reports for this device; peer average 2.05/device2022-07: 0 reports for this device; peer average 3.76/device2022-08: 0 reports for this device; peer average 3.21/device2022-09: 0 reports for this device; peer average 3.18/device2022-10: 0 reports for this device; peer average 2.91/device2022-11: 0 reports for this device; peer average 3.7/device2022-12: 0 reports for this device; peer average 10.85/device2023-01: 0 reports for this device; peer average 20.62/device2023-02: 0 reports for this device; peer average 8.76/device2023-03: 4 reports for this device; peer average 11.74/device2023-04: 0 reports for this device; peer average 12.83/device2023-05: 0 reports for this device; peer average 16.68/device2023-06: 0 reports for this device; peer average 17.52/device2023-07: 4 reports for this device; peer average 11.38/device2023-08: 3 reports for this device; peer average 10.61/device2023-09: 0 reports for this device; peer average 9.27/device2023-10: 0 reports for this device; peer average 10.57/device2023-11: 0 reports for this device; peer average 9.06/device2023-12: 0 reports for this device; peer average 10.81/device2024-01: 5 reports for this device; peer average 8.47/device2024-02: 5 reports for this device; peer average 11.07/device2024-03: 0 reports for this device; peer average 11.65/device2024-04: 4 reports for this device; peer average 9.86/device2024-05: 2 reports for this device; peer average 11.83/device2024-06: 4 reports for this device; peer average 9.03/device2024-07: 4 reports for this device; peer average 9.7/device2024-08: 1 reports for this device; peer average 10.74/device2024-09: 0 reports for this device; peer average 12/device2024-10: 0 reports for this device; peer average 10.05/device2024-11: 6 reports for this device; peer average 7.97/device2024-12: 0 reports for this device; peer average 11.71/device2025-01: 1 reports for this device; peer average 9.85/device2025-02: 0 reports for this device; peer average 12.36/device2025-03: 0 reports for this device; peer average 9.44/device2025-04: 0 reports for this device; peer average 10.03/device2025-05: 0 reports for this device; peer average 9.39/device2025-06: 2 reports for this device; peer average 8.24/device2025-07: 3 reports for this device; peer average 9.1/device2025-08: 0 reports for this device; peer average 9.82/device2025-09: 0 reports for this device; peer average 8.97/device2025-10: 0 reports for this device; peer average 8/device2025-11: 2 reports for this device; peer average 9.32/device2025-12: 0 reports for this device; peer average 9.75/device2026-01: 3 reports for this device; peer average 11.85/device2026-02: 0 reports for this device; peer average 16.95/device2026-03: 3 reports for this device; peer average 7.96/device2026-04: 2 reports for this device; peer average 8.59/device2026-05: 1 reports for this device; peer average 5.76/device2026-06: 2 reports for this device; peer average 7.7/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0103.78
2019-0202.69
2019-0303.27
2019-0404.36
2019-0502.23
2019-0604.77
2019-0704.32
2019-0803
2019-0902.67
2019-1003.18
2019-1102.72
2019-1203.65
2020-0103
2020-0203.67
2020-0303.65
2020-0403.17
2020-0502.3
2020-0605
2020-0702.04
2020-0802.5
2020-0902.26
2020-1003.5
2020-1103.14
2020-1204.21
2021-0102.25
2021-0204.5
2021-0303.95
2021-0403.53
2021-0502.67
2021-0627.33
2021-07010.76
2021-0805.43
2021-0905.22
2021-1007.62
2021-1105.4
2021-1226.65
2022-0125.95
2022-0203.39
2022-0309.28
2022-0404
2022-0504.85
2022-0602.05
2022-0703.76
2022-0803.21
2022-0903.18
2022-1002.91
2022-1103.7
2022-12010.85
2023-01020.62
2023-0208.76
2023-03411.74
2023-04012.83
2023-05016.68
2023-06017.52
2023-07411.38
2023-08310.61
2023-0909.27
2023-10010.57
2023-1109.06
2023-12010.81
2024-0158.47
2024-02511.07
2024-03011.65
2024-0449.86
2024-05211.83
2024-0649.03
2024-0749.7
2024-08110.74
2024-09012
2024-10010.05
2024-1167.97
2024-12011.71
2025-0119.85
2025-02012.36
2025-0309.44
2025-04010.03
2025-0509.39
2025-0628.24
2025-0739.1
2025-0809.82
2025-0908.97
2025-1008
2025-1129.32
2025-1209.75
2026-01311.85
2026-02016.95
2026-0337.96
2026-0428.59
2026-0515.76
2026-0627.7
This device (reports/month)Average device in HIG, HIH (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
2026-06-1625518114MalfunctionAvailablecatalog number
2026-05-063015512350-2026-00007InjuryAvailablecatalog number
2026-04-163015512350-2026-00006InjuryAvailablecatalog number
2026-04-143015512350-2026-00005InjuryAvailablecatalog number
2026-03-303015512-2026-00004InjuryAvailablecatalog number
2026-03-1224579038MalfunctionAvailablecatalog number
2026-01-293015512350-2026-00002InjuryAvailablecatalog number
2026-01-2224144048MalfunctionAvailablecatalog number
2025-11-0623485247MalfunctionAvailablecatalog number
2025-07-0922456441MalfunctionAvailablecatalog number
2025-06-2422318241MalfunctionAvailablecatalog number
2025-01-16MW5164833MalfunctionAvailablecatalog number
2024-11-1920722819MalfunctionAvailablecatalog number
2024-11-0520609334MalfunctionAvailablecatalog number
2024-08-273015512350-2024-00005InjuryAvailablecatalog number

Showing the most recent 35 of 67 linked reports.

Showing 1–15 of 35
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
    2024-05-01NAINo action indicatedMEDITRINA0
    2024-05-01NAINo action indicatedMEDITRINA0
    2023-02-23NAINo action indicatedMEDITRINA0
    2023-02-23NAINo action indicatedMEDITRINA0
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