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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.

82 linked reportsInjury 42Malfunction 40
91726342019-01: 2 reports for this device; peer average 9.07/device2019-02: 0 reports for this device; peer average 8.57/device2019-03: 4 reports for this device; peer average 12.63/device2019-04: 2 reports for this device; peer average 7.71/device2019-05: 0 reports for this device; peer average 11.6/device2019-06: 0 reports for this device; peer average 8.54/device2019-07: 2 reports for this device; peer average 8.04/device2019-08: 2 reports for this device; peer average 8.24/device2019-09: 6 reports for this device; peer average 8.9/device2019-10: 2 reports for this device; peer average 10.13/device2019-11: 0 reports for this device; peer average 9.05/device2019-12: 2 reports for this device; peer average 9.33/device2020-01: 0 reports for this device; peer average 12.14/device2020-02: 2 reports for this device; peer average 9.81/device2020-03: 0 reports for this device; peer average 14.35/device2020-04: 0 reports for this device; peer average 10.59/device2020-05: 0 reports for this device; peer average 5.25/device2020-06: 2 reports for this device; peer average 11.38/device2020-07: 2 reports for this device; peer average 9.04/device2020-08: 0 reports for this device; peer average 7.8/device2020-09: 8 reports for this device; peer average 10.18/device2020-10: 0 reports for this device; peer average 11.14/device2020-11: 0 reports for this device; peer average 14.81/device2020-12: 4 reports for this device; peer average 8.96/device2021-01: 2 reports for this device; peer average 9.95/device2021-02: 0 reports for this device; peer average 9.31/device2021-03: 0 reports for this device; peer average 10.66/device2021-04: 3 reports for this device; peer average 9.61/device2021-05: 0 reports for this device; peer average 6.71/device2021-06: 0 reports for this device; peer average 11.05/device2021-07: 2 reports for this device; peer average 7.93/device2021-08: 0 reports for this device; peer average 12.27/device2021-09: 2 reports for this device; peer average 8.94/device2021-10: 0 reports for this device; peer average 7.52/device2021-11: 11 reports for this device; peer average 7.83/device2021-12: 2 reports for this device; peer average 10.76/device2022-01: 0 reports for this device; peer average 9/device2022-02: 3 reports for this device; peer average 6.09/device2022-03: 2 reports for this device; peer average 7.55/device2022-04: 0 reports for this device; peer average 9.96/device2022-05: 0 reports for this device; peer average 7.58/device2022-06: 0 reports for this device; peer average 11.93/device2022-07: 2 reports for this device; peer average 8.33/device2022-08: 2 reports for this device; peer average 8.97/device2022-09: 0 reports for this device; peer average 10.41/device2022-10: 0 reports for this device; peer average 10.07/device2022-11: 0 reports for this device; peer average 9.12/device2022-12: 2 reports for this device; peer average 16.6/device2023-01: 0 reports for this device; peer average 10.33/device2023-02: 2 reports for this device; peer average 7.77/device2023-03: 7 reports for this device; peer average 9.2/device2023-04: 0 reports for this device; peer average 12.38/device2023-05: 0 reports for this device; peer average 8.15/device2023-06: 0 reports for this device; peer average 16.63/device2023-07: 0 reports for this device; peer average 11.26/device2023-08: 0 reports for this device; peer average 7.85/device2023-09: 0 reports for this device; peer average 14.69/device2023-10: 0 reports for this device; peer average 27.15/device2023-11: 0 reports for this device; peer average 25.5/device2023-12: 0 reports for this device; peer average 19.38/device2024-01: 0 reports for this device; peer average 19.8/device2024-02: 0 reports for this device; peer average 27.42/device2024-03: 0 reports for this device; peer average 18.08/device2024-04: 0 reports for this device; peer average 34.25/device2024-05: 0 reports for this device; peer average 13.94/device2024-06: 0 reports for this device; peer average 14.67/device2024-07: 0 reports for this device; peer average 8.54/device2024-08: 0 reports for this device; peer average 10.39/device2024-09: 0 reports for this device; peer average 18.93/device2024-10: 0 reports for this device; peer average 16.78/device2024-11: 0 reports for this device; peer average 17.14/device2024-12: 0 reports for this device; peer average 15.78/device2025-01: 0 reports for this device; peer average 17.15/device2025-02: 0 reports for this device; peer average 10.29/device2025-03: 0 reports for this device; peer average 20.08/device2025-04: 0 reports for this device; peer average 20.58/device2025-05: 0 reports for this device; peer average 18.5/device2025-06: 0 reports for this device; peer average 15.82/device2025-07: 0 reports for this device; peer average 16.69/device2025-08: 0 reports for this device; peer average 13.43/device2025-09: 0 reports for this device; peer average 15.56/device2025-10: 0 reports for this device; peer average 17.6/device2025-11: 0 reports for this device; peer average 15.55/device2025-12: 0 reports for this device; peer average 25.94/device2026-01: 0 reports for this device; peer average 21.23/device2026-02: 0 reports for this device; peer average 19.12/device2026-03: 0 reports for this device; peer average 17.8/device2026-04: 0 reports for this device; peer average 25.19/device2026-05: 0 reports for this device; peer average 15.94/device2026-06: 0 reports for this device; peer average 20.25/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0129.07
2019-0208.57
2019-03412.63
2019-0427.71
2019-05011.6
2019-0608.54
2019-0728.04
2019-0828.24
2019-0968.9
2019-10210.13
2019-1109.05
2019-1229.33
2020-01012.14
2020-0229.81
2020-03014.35
2020-04010.59
2020-0505.25
2020-06211.38
2020-0729.04
2020-0807.8
2020-09810.18
2020-10011.14
2020-11014.81
2020-1248.96
2021-0129.95
2021-0209.31
2021-03010.66
2021-0439.61
2021-0506.71
2021-06011.05
2021-0727.93
2021-08012.27
2021-0928.94
2021-1007.52
2021-11117.83
2021-12210.76
2022-0109
2022-0236.09
2022-0327.55
2022-0409.96
2022-0507.58
2022-06011.93
2022-0728.33
2022-0828.97
2022-09010.41
2022-10010.07
2022-1109.12
2022-12216.6
2023-01010.33
2023-0227.77
2023-0379.2
2023-04012.38
2023-0508.15
2023-06016.63
2023-07011.26
2023-0807.85
2023-09014.69
2023-10027.15
2023-11025.5
2023-12019.38
2024-01019.8
2024-02027.42
2024-03018.08
2024-04034.25
2024-05013.94
2024-06014.67
2024-0708.54
2024-08010.39
2024-09018.93
2024-10016.78
2024-11017.14
2024-12015.78
2025-01017.15
2025-02010.29
2025-03020.08
2025-04020.58
2025-05018.5
2025-06015.82
2025-07016.69
2025-08013.43
2025-09015.56
2025-10017.6
2025-11015.55
2025-12025.94
2026-01021.23
2026-02019.12
2026-03017.8
2026-04025.19
2026-05015.94
2026-06020.25
This device (reports/month)Average device in FZP (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
2023-03-289610612-2023-00067InjuryAvailablecatalog number
2023-03-159610612-2023-00051MalfunctionAvailablecatalog number
2023-03-089610612-2023-00039MalfunctionAvailablecatalog number
2023-02-249610612-2023-00044InjuryAvailablecatalog number
2022-12-059610612-2022-00360InjuryAvailablecatalog number
2022-08-179610612-2022-00254InjuryAvailablecatalog number
2022-07-199610612-2022-00179InjuryAvailablecatalog number
2022-03-179610612-2022-00076InjuryAvailablecatalog number
2022-02-119610612-2022-00024InjuryAvailablecatalog number
2021-12-159610612-2021-00795InjuryAvailablecatalog number
2021-11-199610612-2021-00689MalfunctionAvailablecatalog number
2021-11-129610612-2021-00740MalfunctionAvailablecatalog number
2021-11-129610612-2021-00742InjuryAvailablecatalog number
2021-11-129610612-2021-00743InjuryAvailablecatalog number
2021-11-129610612-2021-00741InjuryAvailablecatalog number

Showing the most recent 39 of 82 linked reports.

Showing 1–15 of 39
Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2025-07-11NAINo action indicatedAesculap Inc0
2025-07-11NAINo action indicatedAesculap Inc0
2022-07-21NAINo action indicatedAesculap AG0
2022-07-21NAINo action indicatedAesculap AG0
2021-08-11VAIVoluntary action indicatedAesculap Inc3
2021-08-11VAIVoluntary action indicatedAesculap Inc3
2018-06-13VAIVoluntary action indicatedAesculap Inc0
2018-06-13VAIVoluntary action indicatedAesculap Inc0
2016-09-22NAINo action indicatedAesculap AG0
2016-09-22NAINo action indicatedAesculap AG0
2016-09-14VAIVoluntary action indicatedAesculap Inc0
2016-09-14VAIVoluntary action indicatedAesculap Inc0
2016-07-13NAINo action indicatedAesculap Inc0
2016-07-13NAINo action indicatedAesculap Inc0
2015-07-16NAINo action indicatedAesculap AG1
2015-07-16NAINo action indicatedAesculap AG1
2015-05-05NAINo action indicatedAesculap Inc0
2015-05-05NAINo action indicatedAesculap Inc0
2014-10-23NAINo action indicatedAesculap Inc0
2014-10-23NAINo action indicatedAesculap Inc0
2011-09-26WLWarning LetterAesculap AG—
2011-09-26WLWarning LetterAesculap AG—
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