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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.

48 linked reportsMalfunction 33Injury 15
369122019-01: 0 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 2.71/device2019-04: 0 reports for this device; peer average 1.5/device2019-05: 0 reports for this device; peer average 2/device2019-06: 0 reports for this device; peer average 1.29/device2019-07: 0 reports for this device; peer average 1.75/device2019-08: 0 reports for this device; peer average 2.5/device2019-09: 2 reports for this device; peer average 1.83/device2019-10: 0 reports for this device; peer average 2/device2019-11: 0 reports for this device; peer average 2.5/device2019-12: 2 reports for this device; peer average 7/device2020-01: 0 reports for this device; peer average 2.25/device2020-02: 0 reports for this device; peer average 1.83/device2020-03: 0 reports for this device; peer average 2.8/device2020-04: 0 reports for this device; peer average 2.2/device2020-05: 0 reports for this device; peer average 2.22/device2020-06: 2 reports for this device; peer average 2.78/device2020-07: 0 reports for this device; peer average 2.67/device2020-08: 2 reports for this device; peer average 1.9/device2020-09: 0 reports for this device; peer average 4/device2020-10: 0 reports for this device; peer average 2.25/device2020-11: 0 reports for this device; peer average 2.14/device2020-12: 0 reports for this device; peer average 2.33/device2021-01: 0 reports for this device; peer average 2/device2021-02: 5 reports for this device; peer average 2.5/device2021-03: 0 reports for this device; peer average 3.67/device2021-04: 3 reports for this device; peer average 3.8/device2021-05: 3 reports for this device; peer average 2.4/device2021-06: 0 reports for this device; peer average 2.5/device2021-07: 0 reports for this device; peer average 1.17/device2021-08: 2 reports for this device; peer average 2.67/device2021-09: 2 reports for this device; peer average 2/device2021-10: 0 reports for this device; peer average 2.86/device2021-11: 0 reports for this device; peer average 1.8/device2021-12: 12 reports for this device; peer average 2.86/device2022-01: 3 reports for this device; peer average 2.67/device2022-02: 0 reports for this device; peer average 6.25/device2022-03: 0 reports for this device; peer average 4.67/device2022-04: 0 reports for this device; peer average 1.25/device2022-05: 2 reports for this device; peer average 1.67/device2022-06: 0 reports for this device; peer average 5.33/device2022-07: 0 reports for this device; peer average 1.5/device2022-08: 0 reports for this device; peer average 2/device2022-09: 0 reports for this device; peer average 1.5/device2022-10: 0 reports for this device; peer average 1/device2022-11: 0 reports for this device; peer average 1.33/device2022-12: 0 reports for this device; peer average 3.91/device2023-01: 0 reports for this device; peer average 3/device2023-02: 0 reports for this device; peer average 2/device2023-03: 0 reports for this device; peer average 4.75/device2023-04: 0 reports for this device; peer average 1.67/device2023-05: 0 reports for this device; peer average 1/device2023-06: 0 reports for this device; peer average 9.4/device2023-07: 0 reports for this device; peer average 1.8/device2023-08: 0 reports for this device; peer average 2.33/device2023-09: 0 reports for this device; peer average 2.75/device2023-10: 0 reports for this device; peer average 2/device2023-11: 2 reports for this device; peer average 5.5/device2023-12: 0 reports for this device; peer average 1.4/device2024-01: 0 reports for this device; peer average 4.67/device2024-02: 0 reports for this device; peer average 3/device2024-03: 0 reports for this device; peer average 4/device2024-04: 0 reports for this device; peer average 3.25/device2024-05: 0 reports for this device; peer average 1.5/device2024-06: 0 reports for this device; peer average 2/device2024-07: 0 reports for this device; peer average 1/device2024-08: 0 reports for this device; peer average 1.4/device2024-09: 0 reports for this device; peer average 4/device2024-10: 0 reports for this device; peer average 4.5/device2024-11: 0 reports for this device; peer average 3.5/device2024-12: 0 reports for this device; peer average 1.67/device2025-01: 0 reports for this device; peer average 1.67/device2025-03: 0 reports for this device; peer average 2.5/device2025-04: 6 reports for this device; peer average 3.5/device2025-05: 0 reports for this device; peer average 3/device2025-06: 0 reports for this device; peer average 3/device2025-07: 0 reports for this device; peer average 4.5/device2025-08: 0 reports for this device; peer average 1.5/device2025-10: 0 reports for this device; peer average 1.5/device2025-11: 0 reports for this device; peer average 1/device2025-12: 0 reports for this device; peer average 6.5/device2026-01: 0 reports for this device; peer average 2.17/device2026-02: 0 reports for this device; peer average 3/device2026-03: 0 reports for this device; peer average 1/device2026-04: 0 reports for this device; peer average 8/device2026-05: 0 reports for this device; peer average 3.4/device2026-06: 0 reports for this device; peer average 7.5/device01020304050607080910111201020304050607080910111201020304050607080910111201020304050607080910111201020304050607080910111201020304050607080910111201030405060708101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.5
2019-0201
2019-0302.71
2019-0401.5
2019-0502
2019-0601.29
2019-0701.75
2019-0802.5
2019-0921.83
2019-1002
2019-1102.5
2019-1227
2020-0102.25
2020-0201.83
2020-0302.8
2020-0402.2
2020-0502.22
2020-0622.78
2020-0702.67
2020-0821.9
2020-0904
2020-1002.25
2020-1102.14
2020-1202.33
2021-0102
2021-0252.5
2021-0303.67
2021-0433.8
2021-0532.4
2021-0602.5
2021-0701.17
2021-0822.67
2021-0922
2021-1002.86
2021-1101.8
2021-12122.86
2022-0132.67
2022-0206.25
2022-0304.67
2022-0401.25
2022-0521.67
2022-0605.33
2022-0701.5
2022-0802
2022-0901.5
2022-1001
2022-1101.33
2022-1203.91
2023-0103
2023-0202
2023-0304.75
2023-0401.67
2023-0501
2023-0609.4
2023-0701.8
2023-0802.33
2023-0902.75
2023-1002
2023-1125.5
2023-1201.4
2024-0104.67
2024-0203
2024-0304
2024-0403.25
2024-0501.5
2024-0602
2024-0701
2024-0801.4
2024-0904
2024-1004.5
2024-1103.5
2024-1201.67
2025-0101.67
2025-0302.5
2025-0463.5
2025-0503
2025-0603
2025-0704.5
2025-0801.5
2025-1001.5
2025-1101
2025-1206.5
2026-0102.17
2026-0203
2026-0301
2026-0408
2026-0503.4
2026-0607.5
This device (reports/month)Average device in GXR (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
2025-04-299610612-2025-00070MalfunctionAvailablecatalog number
2025-04-299610612-2025-00069InjuryAvailablecatalog number
2025-04-299610612-2025-00071MalfunctionAvailablecatalog number
2023-11-139610612-2023-00246InjuryAvailablecatalog number
2022-05-119610612-2022-00118InjuryAvailablecatalog number
2022-01-039610612-2021-00792MalfunctionAvailablecatalog number
2021-12-209610612-2021-00777MalfunctionAvailablecatalog number
2021-12-209610612-2021-00776InjuryAvailablecatalog number
2021-12-089610612-2021-00775InjuryAvailablecatalog number
2021-12-039610612-2021-00772MalfunctionAvailablecatalog number
2021-09-179610612-2021-00534MalfunctionAvailablecatalog number
2021-08-189610612-2021-00567MalfunctionAvailablecatalog number
2021-05-079610612-2021-00401MalfunctionAvailablecatalog number
2021-04-209610612-2021-00353MalfunctionAvailablecatalog number
2021-02-179610612-2021-00097MalfunctionAvailablecatalog number

Showing the most recent 20 of 48 linked reports.

Showing 1–15 of 20
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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