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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.

42 linked reportsMalfunction 24Injury 18
368112019-01: 0 reports for this device; peer average 4.33/device2019-02: 0 reports for this device; peer average 5.22/device2019-03: 4 reports for this device; peer average 5.13/device2019-04: 2 reports for this device; peer average 5.93/device2019-05: 0 reports for this device; peer average 5.62/device2019-06: 8 reports for this device; peer average 4.83/device2019-07: 0 reports for this device; peer average 5.82/device2019-08: 0 reports for this device; peer average 3.1/device2019-09: 0 reports for this device; peer average 3.7/device2019-10: 0 reports for this device; peer average 4.36/device2019-11: 2 reports for this device; peer average 3.78/device2019-12: 0 reports for this device; peer average 5.45/device2020-01: 0 reports for this device; peer average 4.56/device2020-02: 0 reports for this device; peer average 2.78/device2020-03: 0 reports for this device; peer average 4.5/device2020-04: 0 reports for this device; peer average 3.1/device2020-05: 0 reports for this device; peer average 2/device2020-06: 0 reports for this device; peer average 2.44/device2020-07: 4 reports for this device; peer average 3.77/device2020-08: 0 reports for this device; peer average 2.3/device2020-09: 0 reports for this device; peer average 4.22/device2020-10: 0 reports for this device; peer average 4.55/device2020-11: 0 reports for this device; peer average 4.6/device2020-12: 0 reports for this device; peer average 3.54/device2021-01: 0 reports for this device; peer average 3.67/device2021-02: 0 reports for this device; peer average 3.25/device2021-03: 2 reports for this device; peer average 4/device2021-04: 2 reports for this device; peer average 3.77/device2021-05: 0 reports for this device; peer average 2.92/device2021-06: 0 reports for this device; peer average 4.33/device2021-07: 0 reports for this device; peer average 2.92/device2021-08: 0 reports for this device; peer average 4.17/device2021-09: 0 reports for this device; peer average 3.43/device2021-10: 0 reports for this device; peer average 2.91/device2021-11: 0 reports for this device; peer average 3.36/device2021-12: 2 reports for this device; peer average 3.75/device2022-01: 0 reports for this device; peer average 4/device2022-02: 0 reports for this device; peer average 4.33/device2022-03: 0 reports for this device; peer average 3.4/device2022-04: 2 reports for this device; peer average 3.27/device2022-05: 0 reports for this device; peer average 6.4/device2022-06: 2 reports for this device; peer average 6.67/device2022-07: 0 reports for this device; peer average 5/device2022-08: 0 reports for this device; peer average 4.67/device2022-09: 0 reports for this device; peer average 2.93/device2022-10: 5 reports for this device; peer average 3.82/device2022-11: 2 reports for this device; peer average 3.18/device2022-12: 0 reports for this device; peer average 2.83/device2023-01: 0 reports for this device; peer average 3.67/device2023-02: 0 reports for this device; peer average 3.5/device2023-03: 0 reports for this device; peer average 3.69/device2023-04: 0 reports for this device; peer average 3.55/device2023-05: 0 reports for this device; peer average 3.39/device2023-06: 2 reports for this device; peer average 2.68/device2023-07: 0 reports for this device; peer average 3.75/device2023-08: 0 reports for this device; peer average 3.25/device2023-09: 0 reports for this device; peer average 3.07/device2023-10: 0 reports for this device; peer average 5.38/device2023-11: 0 reports for this device; peer average 3.22/device2023-12: 3 reports for this device; peer average 4.73/device2024-01: 0 reports for this device; peer average 4.55/device2024-02: 0 reports for this device; peer average 3.22/device2024-03: 0 reports for this device; peer average 2.73/device2024-04: 0 reports for this device; peer average 3.75/device2024-05: 0 reports for this device; peer average 2.14/device2024-06: 0 reports for this device; peer average 3.54/device2024-07: 0 reports for this device; peer average 2.58/device2024-08: 0 reports for this device; peer average 2.71/device2024-09: 0 reports for this device; peer average 3.21/device2024-10: 0 reports for this device; peer average 3.6/device2024-11: 0 reports for this device; peer average 3.43/device2024-12: 0 reports for this device; peer average 1.8/device2025-01: 0 reports for this device; peer average 5/device2025-02: 0 reports for this device; peer average 4.15/device2025-03: 0 reports for this device; peer average 4.33/device2025-04: 0 reports for this device; peer average 4.22/device2025-05: 0 reports for this device; peer average 4.45/device2025-06: 0 reports for this device; peer average 4.65/device2025-07: 0 reports for this device; peer average 5.56/device2025-08: 0 reports for this device; peer average 4.33/device2025-09: 0 reports for this device; peer average 2.5/device2025-10: 0 reports for this device; peer average 3.13/device2025-11: 0 reports for this device; peer average 4.64/device2025-12: 0 reports for this device; peer average 6.5/device2026-01: 0 reports for this device; peer average 4.29/device2026-02: 0 reports for this device; peer average 4.42/device2026-03: 0 reports for this device; peer average 5.57/device2026-04: 0 reports for this device; peer average 7.07/device2026-05: 0 reports for this device; peer average 11.14/device2026-06: 0 reports for this device; peer average 7.69/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0104.33
2019-0205.22
2019-0345.13
2019-0425.93
2019-0505.62
2019-0684.83
2019-0705.82
2019-0803.1
2019-0903.7
2019-1004.36
2019-1123.78
2019-1205.45
2020-0104.56
2020-0202.78
2020-0304.5
2020-0403.1
2020-0502
2020-0602.44
2020-0743.77
2020-0802.3
2020-0904.22
2020-1004.55
2020-1104.6
2020-1203.54
2021-0103.67
2021-0203.25
2021-0324
2021-0423.77
2021-0502.92
2021-0604.33
2021-0702.92
2021-0804.17
2021-0903.43
2021-1002.91
2021-1103.36
2021-1223.75
2022-0104
2022-0204.33
2022-0303.4
2022-0423.27
2022-0506.4
2022-0626.67
2022-0705
2022-0804.67
2022-0902.93
2022-1053.82
2022-1123.18
2022-1202.83
2023-0103.67
2023-0203.5
2023-0303.69
2023-0403.55
2023-0503.39
2023-0622.68
2023-0703.75
2023-0803.25
2023-0903.07
2023-1005.38
2023-1103.22
2023-1234.73
2024-0104.55
2024-0203.22
2024-0302.73
2024-0403.75
2024-0502.14
2024-0603.54
2024-0702.58
2024-0802.71
2024-0903.21
2024-1003.6
2024-1103.43
2024-1201.8
2025-0105
2025-0204.15
2025-0304.33
2025-0404.22
2025-0504.45
2025-0604.65
2025-0705.56
2025-0804.33
2025-0902.5
2025-1003.13
2025-1104.64
2025-1206.5
2026-0104.29
2026-0204.42
2026-0305.57
2026-0407.07
2026-05011.14
2026-0607.69
This device (reports/month)Average device in OCW (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
2023-12-289610612-2023-00275InjuryAvailablecatalog number
2023-12-272916714-2023-00127InjuryAvailableexact di
2023-06-289610612-2023-00165InjuryAvailablecatalog number
2022-11-219610612-2022-00341InjuryAvailablecatalog number
2022-10-319610612-2022-00331InjuryAvailablecatalog number
2022-10-299610612-2022-00307InjuryAvailablecatalog number
2022-06-229610612-2022-00165MalfunctionAvailablecatalog number
2022-04-269610612-2022-00124InjuryAvailablecatalog number
2021-12-239610612-2021-00714MalfunctionAvailablecatalog number
2021-04-019610612-2021-00281MalfunctionAvailablecatalog number
2021-03-259610612-2021-00192InjuryAvailablecatalog number
2020-07-169610612-2020-00279MalfunctionAvailablecatalog number
2020-07-169610612-2020-00278MalfunctionAvailablecatalog number
2019-11-079610612-2019-00720MalfunctionAvailablecatalog number
2019-06-069610612-2019-00370MalfunctionAvailablecatalog number

Showing the most recent 21 of 42 linked reports.

Showing 1–15 of 21
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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