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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.

71 linked reportsInjury 64Malfunction 7
358102019-01: 2 reports for this device; peer average 1.5/device2019-02: 0 reports for this device; peer average 1/device2019-03: 0 reports for this device; peer average 1.33/device2019-04: 0 reports for this device; peer average 1/device2019-05: 0 reports for this device; peer average 2.2/device2019-06: 6 reports for this device; peer average 1.96/device2019-07: 0 reports for this device; peer average 1.89/device2019-09: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 3.25/device2019-12: 0 reports for this device; peer average 2.5/device2020-01: 4 reports for this device; peer average 1.83/device2020-03: 2 reports for this device; peer average 2.67/device2020-04: 0 reports for this device; peer average 1.5/device2020-05: 4 reports for this device; peer average 3/device2020-06: 0 reports for this device; peer average 1.5/device2020-07: 10 reports for this device; peer average 4.67/device2020-08: 8 reports for this device; peer average 3.11/device2020-09: 0 reports for this device; peer average 1.5/device2020-10: 4 reports for this device; peer average 2.36/device2020-11: 0 reports for this device; peer average 1.6/device2020-12: 0 reports for this device; peer average 1.5/device2021-01: 5 reports for this device; peer average 3.33/device2021-02: 2 reports for this device; peer average 1.5/device2021-03: 0 reports for this device; peer average 2.56/device2021-04: 0 reports for this device; peer average 3.33/device2021-05: 3 reports for this device; peer average 1.67/device2021-06: 0 reports for this device; peer average 2.29/device2021-07: 0 reports for this device; peer average 1.67/device2021-08: 0 reports for this device; peer average 1.83/device2021-09: 0 reports for this device; peer average 1.6/device2021-11: 0 reports for this device; peer average 3.82/device2021-12: 3 reports for this device; peer average 3/device2022-01: 3 reports for this device; peer average 3.83/device2022-02: 0 reports for this device; peer average 1.5/device2022-03: 0 reports for this device; peer average 2.5/device2022-04: 0 reports for this device; peer average 1.2/device2022-05: 0 reports for this device; peer average 1.67/device2022-06: 3 reports for this device; peer average 2.25/device2022-07: 0 reports for this device; peer average 1.5/device2022-08: 5 reports for this device; peer average 2.67/device2022-09: 0 reports for this device; peer average 1.33/device2022-10: 0 reports for this device; peer average 1.25/device2022-11: 2 reports for this device; peer average 1.6/device2022-12: 0 reports for this device; peer average 1.67/device2023-01: 0 reports for this device; peer average 4.6/device2023-02: 0 reports for this device; peer average 1.2/device2023-03: 0 reports for this device; peer average 1.43/device2023-04: 0 reports for this device; peer average 1.33/device2023-05: 0 reports for this device; peer average 1.9/device2023-06: 0 reports for this device; peer average 1.25/device2023-07: 0 reports for this device; peer average 1.5/device2023-08: 0 reports for this device; peer average 1.8/device2023-09: 0 reports for this device; peer average 1.29/device2023-10: 0 reports for this device; peer average 1.3/device2023-11: 0 reports for this device; peer average 1.75/device2023-12: 0 reports for this device; peer average 1.25/device2024-01: 0 reports for this device; peer average 2.22/device2024-02: 0 reports for this device; peer average 2.22/device2024-03: 0 reports for this device; peer average 1.68/device2024-04: 0 reports for this device; peer average 1.22/device2024-05: 5 reports for this device; peer average 2.89/device2024-06: 0 reports for this device; peer average 2.83/device2024-07: 0 reports for this device; peer average 1.6/device2024-08: 0 reports for this device; peer average 1.7/device2024-09: 0 reports for this device; peer average 1.89/device2024-10: 0 reports for this device; peer average 1.45/device2024-11: 0 reports for this device; peer average 1.88/device2024-12: 0 reports for this device; peer average 2.1/device2025-01: 0 reports for this device; peer average 2.32/device2025-02: 0 reports for this device; peer average 2.17/device2025-03: 0 reports for this device; peer average 2/device2025-04: 0 reports for this device; peer average 1/device2025-05: 0 reports for this device; peer average 1.25/device2025-06: 0 reports for this device; peer average 1.8/device2025-07: 0 reports for this device; peer average 1.8/device2025-08: 0 reports for this device; peer average 2.15/device2025-09: 0 reports for this device; peer average 1.93/device2025-10: 0 reports for this device; peer average 1.53/device2025-11: 0 reports for this device; peer average 3/device2025-12: 0 reports for this device; peer average 1.8/device2026-01: 0 reports for this device; peer average 1.73/device2026-02: 0 reports for this device; peer average 1.44/device2026-03: 0 reports for this device; peer average 1.88/device2026-04: 0 reports for this device; peer average 1.93/device2026-05: 0 reports for this device; peer average 2.38/device2026-06: 0 reports for this device; peer average 1.75/device0102030405060709101201030405060708091011120102030405060708091112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0121.5
2019-0201
2019-0301.33
2019-0401
2019-0502.2
2019-0661.96
2019-0701.89
2019-0901
2019-1003.25
2019-1202.5
2020-0141.83
2020-0322.67
2020-0401.5
2020-0543
2020-0601.5
2020-07104.67
2020-0883.11
2020-0901.5
2020-1042.36
2020-1101.6
2020-1201.5
2021-0153.33
2021-0221.5
2021-0302.56
2021-0403.33
2021-0531.67
2021-0602.29
2021-0701.67
2021-0801.83
2021-0901.6
2021-1103.82
2021-1233
2022-0133.83
2022-0201.5
2022-0302.5
2022-0401.2
2022-0501.67
2022-0632.25
2022-0701.5
2022-0852.67
2022-0901.33
2022-1001.25
2022-1121.6
2022-1201.67
2023-0104.6
2023-0201.2
2023-0301.43
2023-0401.33
2023-0501.9
2023-0601.25
2023-0701.5
2023-0801.8
2023-0901.29
2023-1001.3
2023-1101.75
2023-1201.25
2024-0102.22
2024-0202.22
2024-0301.68
2024-0401.22
2024-0552.89
2024-0602.83
2024-0701.6
2024-0801.7
2024-0901.89
2024-1001.45
2024-1101.88
2024-1202.1
2025-0102.32
2025-0202.17
2025-0302
2025-0401
2025-0501.25
2025-0601.8
2025-0701.8
2025-0802.15
2025-0901.93
2025-1001.53
2025-1103
2025-1201.8
2026-0101.73
2026-0201.44
2026-0301.88
2026-0401.93
2026-0502.38
2026-0601.75
This device (reports/month)Average device in MJO (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
2024-05-159610612-2024-00149InjuryAvailablecatalog number
2024-05-032916714-2024-00078InjuryAvailablecatalog number
2022-11-169610612-2022-00353InjuryAvailablecatalog number
2022-08-109610612-2022-00231InjuryAvailablecatalog number
2022-08-102916714-2022-00079InjuryAvailablecatalog number
2022-06-229610612-2022-00134InjuryAvailablecatalog number
2022-01-119610612-2022-00003InjuryAvailablecatalog number
2021-12-299610612-2021-00797InjuryAvailablecatalog number
2021-05-119610612-2021-00374MalfunctionAvailablecatalog number
2021-02-059610612-2021-00056InjuryAvailablecatalog number
2021-01-072916714-2021-00002InjuryAvailablecatalog number
2021-01-069610612-2020-00957InjuryAvailablecatalog number
2020-10-229610612-2020-00648InjuryAvailablecatalog number
2020-10-012916714-2020-00487InjuryAvailablecatalog number
2020-08-252916714-2020-00402InjuryAvailablecatalog number

Showing the most recent 30 of 71 linked reports.

Showing 1–15 of 30
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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