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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.

65 linked reportsMalfunction 55Injury 10
61218242019-01: 0 reports for this device; peer average 1.41/device2019-02: 0 reports for this device; peer average 1.33/device2019-03: 0 reports for this device; peer average 2.41/device2019-04: 0 reports for this device; peer average 2.95/device2019-05: 0 reports for this device; peer average 3.31/device2019-06: 0 reports for this device; peer average 1.41/device2019-07: 0 reports for this device; peer average 1.76/device2019-08: 0 reports for this device; peer average 2/device2019-09: 0 reports for this device; peer average 2.17/device2019-10: 0 reports for this device; peer average 2.53/device2019-11: 0 reports for this device; peer average 1.72/device2019-12: 2 reports for this device; peer average 2.35/device2020-01: 0 reports for this device; peer average 2.54/device2020-02: 0 reports for this device; peer average 1.83/device2020-03: 0 reports for this device; peer average 2.06/device2020-04: 0 reports for this device; peer average 2.13/device2020-05: 0 reports for this device; peer average 2.31/device2020-06: 0 reports for this device; peer average 2/device2020-07: 0 reports for this device; peer average 2.17/device2020-08: 0 reports for this device; peer average 2.21/device2020-09: 2 reports for this device; peer average 2.06/device2020-10: 0 reports for this device; peer average 2.22/device2020-11: 0 reports for this device; peer average 1.71/device2020-12: 0 reports for this device; peer average 1.9/device2021-01: 0 reports for this device; peer average 2.13/device2021-02: 0 reports for this device; peer average 1.25/device2021-03: 0 reports for this device; peer average 2/device2021-04: 2 reports for this device; peer average 3.33/device2021-05: 0 reports for this device; peer average 4.09/device2021-06: 3 reports for this device; peer average 1.93/device2021-07: 3 reports for this device; peer average 1.33/device2021-08: 6 reports for this device; peer average 3.31/device2021-09: 3 reports for this device; peer average 1.58/device2021-10: 0 reports for this device; peer average 2.12/device2021-11: 5 reports for this device; peer average 2/device2021-12: 24 reports for this device; peer average 3.93/device2022-01: 0 reports for this device; peer average 2/device2022-02: 7 reports for this device; peer average 2.67/device2022-03: 4 reports for this device; peer average 3.5/device2022-04: 4 reports for this device; peer average 2.36/device2022-05: 0 reports for this device; peer average 1.77/device2022-06: 0 reports for this device; peer average 2.5/device2022-07: 0 reports for this device; peer average 2.16/device2022-08: 0 reports for this device; peer average 2.15/device2022-09: 0 reports for this device; peer average 1.5/device2022-10: 0 reports for this device; peer average 6.64/device2022-11: 0 reports for this device; peer average 2.27/device2022-12: 0 reports for this device; peer average 3.37/device2023-01: 0 reports for this device; peer average 2.67/device2023-02: 0 reports for this device; peer average 3.26/device2023-03: 0 reports for this device; peer average 2.67/device2023-04: 0 reports for this device; peer average 1.5/device2023-05: 0 reports for this device; peer average 2.88/device2023-06: 0 reports for this device; peer average 4.15/device2023-07: 0 reports for this device; peer average 3.81/device2023-08: 0 reports for this device; peer average 3.07/device2023-09: 0 reports for this device; peer average 2.58/device2023-10: 0 reports for this device; peer average 1.44/device2023-11: 0 reports for this device; peer average 2.68/device2023-12: 0 reports for this device; peer average 2.05/device2024-01: 0 reports for this device; peer average 2.89/device2024-02: 0 reports for this device; peer average 2.67/device2024-03: 0 reports for this device; peer average 2.23/device2024-04: 0 reports for this device; peer average 2.61/device2024-05: 0 reports for this device; peer average 2.29/device2024-06: 0 reports for this device; peer average 1.83/device2024-07: 0 reports for this device; peer average 1.55/device2024-08: 0 reports for this device; peer average 1.6/device2024-09: 0 reports for this device; peer average 2.07/device2024-10: 0 reports for this device; peer average 2.29/device2024-11: 0 reports for this device; peer average 2.75/device2024-12: 0 reports for this device; peer average 1.7/device2025-01: 0 reports for this device; peer average 1.5/device2025-02: 0 reports for this device; peer average 1.38/device2025-03: 0 reports for this device; peer average 2/device2025-04: 0 reports for this device; peer average 1.9/device2025-05: 0 reports for this device; peer average 2.27/device2025-06: 0 reports for this device; peer average 2/device2025-07: 0 reports for this device; peer average 4.1/device2025-08: 0 reports for this device; peer average 2.57/device2025-09: 0 reports for this device; peer average 1.69/device2025-10: 0 reports for this device; peer average 1.95/device2025-11: 0 reports for this device; peer average 1.53/device2025-12: 0 reports for this device; peer average 4.38/device2026-01: 0 reports for this device; peer average 1.57/device2026-02: 0 reports for this device; peer average 2.45/device2026-03: 0 reports for this device; peer average 1.11/device2026-04: 0 reports for this device; peer average 3.09/device2026-05: 0 reports for this device; peer average 2.1/device2026-06: 0 reports for this device; peer average 3.56/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.41
2019-0201.33
2019-0302.41
2019-0402.95
2019-0503.31
2019-0601.41
2019-0701.76
2019-0802
2019-0902.17
2019-1002.53
2019-1101.72
2019-1222.35
2020-0102.54
2020-0201.83
2020-0302.06
2020-0402.13
2020-0502.31
2020-0602
2020-0702.17
2020-0802.21
2020-0922.06
2020-1002.22
2020-1101.71
2020-1201.9
2021-0102.13
2021-0201.25
2021-0302
2021-0423.33
2021-0504.09
2021-0631.93
2021-0731.33
2021-0863.31
2021-0931.58
2021-1002.12
2021-1152
2021-12243.93
2022-0102
2022-0272.67
2022-0343.5
2022-0442.36
2022-0501.77
2022-0602.5
2022-0702.16
2022-0802.15
2022-0901.5
2022-1006.64
2022-1102.27
2022-1203.37
2023-0102.67
2023-0203.26
2023-0302.67
2023-0401.5
2023-0502.88
2023-0604.15
2023-0703.81
2023-0803.07
2023-0902.58
2023-1001.44
2023-1102.68
2023-1202.05
2024-0102.89
2024-0202.67
2024-0302.23
2024-0402.61
2024-0502.29
2024-0601.83
2024-0701.55
2024-0801.6
2024-0902.07
2024-1002.29
2024-1102.75
2024-1201.7
2025-0101.5
2025-0201.38
2025-0302
2025-0401.9
2025-0502.27
2025-0602
2025-0704.1
2025-0802.57
2025-0901.69
2025-1001.95
2025-1101.53
2025-1204.38
2026-0101.57
2026-0202.45
2026-0301.11
2026-0403.09
2026-0502.1
2026-0603.56
This device (reports/month)Average device in JEY (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
2022-04-019610612-2022-00084MalfunctionAvailablecatalog number
2022-04-019610612-2022-00085MalfunctionAvailablecatalog number
2022-03-319610612-2022-00083MalfunctionAvailablecatalog number
2022-03-159610612-2022-00074MalfunctionAvailablecatalog number
2022-02-289610612-2022-00061MalfunctionAvailablecatalog number
2022-02-229610612-2022-00062MalfunctionAvailablecatalog number
2022-02-119610612-2022-00016InjuryAvailablecatalog number
2021-12-039610612-2021-00768MalfunctionAvailablecatalog number
2021-12-039610612-2021-00767MalfunctionAvailablecatalog number
2021-12-039610612-2021-00763MalfunctionAvailablecatalog number
2021-12-039610612-2021-00765MalfunctionAvailablecatalog number
2021-12-039610612-2021-00732MalfunctionAvailablecatalog number
2021-12-039610612-2021-00764MalfunctionAvailablecatalog number
2021-12-029610612-2021-00760MalfunctionAvailablecatalog number
2021-12-029610612-2021-00755MalfunctionAvailablecatalog number

Showing the most recent 26 of 65 linked reports.

Showing 1–15 of 26
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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