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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.

20 linked reportsMalfunction 20
4711142019-01: 0 reports for this device; peer average 3/device2019-02: 0 reports for this device; peer average 3.4/device2019-03: 0 reports for this device; peer average 2/device2019-04: 0 reports for this device; peer average 2.56/device2019-05: 0 reports for this device; peer average 1.75/device2019-06: 0 reports for this device; peer average 2/device2019-07: 0 reports for this device; peer average 4.33/device2019-08: 0 reports for this device; peer average 1.5/device2019-09: 0 reports for this device; peer average 2.83/device2019-10: 0 reports for this device; peer average 1.67/device2019-11: 0 reports for this device; peer average 2/device2019-12: 0 reports for this device; peer average 2.5/device2020-01: 0 reports for this device; peer average 1/device2020-02: 0 reports for this device; peer average 1/device2020-03: 0 reports for this device; peer average 3.5/device2020-05: 0 reports for this device; peer average 1.33/device2020-06: 0 reports for this device; peer average 2/device2020-07: 0 reports for this device; peer average 2.44/device2020-08: 0 reports for this device; peer average 4/device2020-09: 2 reports for this device; peer average 2.25/device2020-10: 0 reports for this device; peer average 5.13/device2020-11: 0 reports for this device; peer average 2.5/device2020-12: 0 reports for this device; peer average 3/device2021-01: 0 reports for this device; peer average 2.67/device2021-02: 0 reports for this device; peer average 3.33/device2021-03: 0 reports for this device; peer average 5.11/device2021-04: 0 reports for this device; peer average 3/device2021-05: 0 reports for this device; peer average 2.5/device2021-06: 0 reports for this device; peer average 2/device2021-07: 1 reports for this device; peer average 1.75/device2021-08: 0 reports for this device; peer average 3.67/device2021-09: 0 reports for this device; peer average 1/device2021-10: 0 reports for this device; peer average 1.5/device2021-11: 0 reports for this device; peer average 2.25/device2021-12: 2 reports for this device; peer average 1.8/device2022-01: 0 reports for this device; peer average 2/device2022-02: 0 reports for this device; peer average 1/device2022-03: 0 reports for this device; peer average 1.5/device2022-04: 0 reports for this device; peer average 14.33/device2022-05: 0 reports for this device; peer average 1/device2022-06: 0 reports for this device; peer average 2.5/device2022-07: 0 reports for this device; peer average 4/device2022-08: 0 reports for this device; peer average 1.5/device2022-09: 0 reports for this device; peer average 4/device2022-10: 1 reports for this device; peer average 2/device2022-11: 0 reports for this device; peer average 3/device2022-12: 0 reports for this device; peer average 4.75/device2023-01: 0 reports for this device; peer average 1/device2023-02: 0 reports for this device; peer average 1/device2023-03: 0 reports for this device; peer average 1.5/device2023-04: 0 reports for this device; peer average 1/device2023-05: 0 reports for this device; peer average 1.5/device2023-06: 0 reports for this device; peer average 3.6/device2023-07: 0 reports for this device; peer average 1/device2023-08: 0 reports for this device; peer average 1/device2023-09: 0 reports for this device; peer average 1/device2023-11: 0 reports for this device; peer average 1.5/device2023-12: 0 reports for this device; peer average 1.67/device2024-01: 0 reports for this device; peer average 1/device2024-02: 0 reports for this device; peer average 1/device2024-03: 0 reports for this device; peer average 1/device2024-04: 0 reports for this device; peer average 1/device2024-05: 0 reports for this device; peer average 2.5/device2024-06: 0 reports for this device; peer average 1.75/device2024-08: 0 reports for this device; peer average 1/device2024-10: 1 reports for this device; peer average 1.4/device2024-11: 0 reports for this device; peer average 1/device2024-12: 0 reports for this device; peer average 1/device2025-02: 0 reports for this device; peer average 1/device2025-03: 0 reports for this device; peer average 1/device2025-04: 0 reports for this device; peer average 2.25/device2025-05: 7 reports for this device; peer average 7/device2025-06: 6 reports for this device; peer average 6/device2025-08: 0 reports for this device; peer average 2/device2025-11: 0 reports for this device; peer average 1/device2025-12: 0 reports for this device; peer average 1.33/device2026-01: 0 reports for this device; peer average 1/device2026-02: 0 reports for this device; peer average 1/device2026-05: 0 reports for this device; peer average 1.5/device2026-06: 0 reports for this device; peer average 1/device0102030405060708091011120102030506070809101112010203040506070809101112010203040506070809101112010203040506070809111201020304050608101112020304050608111201020506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0103
2019-0203.4
2019-0302
2019-0402.56
2019-0501.75
2019-0602
2019-0704.33
2019-0801.5
2019-0902.83
2019-1001.67
2019-1102
2019-1202.5
2020-0101
2020-0201
2020-0303.5
2020-0501.33
2020-0602
2020-0702.44
2020-0804
2020-0922.25
2020-1005.13
2020-1102.5
2020-1203
2021-0102.67
2021-0203.33
2021-0305.11
2021-0403
2021-0502.5
2021-0602
2021-0711.75
2021-0803.67
2021-0901
2021-1001.5
2021-1102.25
2021-1221.8
2022-0102
2022-0201
2022-0301.5
2022-04014.33
2022-0501
2022-0602.5
2022-0704
2022-0801.5
2022-0904
2022-1012
2022-1103
2022-1204.75
2023-0101
2023-0201
2023-0301.5
2023-0401
2023-0501.5
2023-0603.6
2023-0701
2023-0801
2023-0901
2023-1101.5
2023-1201.67
2024-0101
2024-0201
2024-0301
2024-0401
2024-0502.5
2024-0601.75
2024-0801
2024-1011.4
2024-1101
2024-1201
2025-0201
2025-0301
2025-0402.25
2025-0577
2025-0666
2025-0802
2025-1101
2025-1201.33
2026-0101
2026-0201
2026-0501.5
2026-0601
This device (reports/month)Average device in LRY (reports/device/month)
Failure-mode summaryAI-generated

20 linked report narratives available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2025-06-040002242056-2025-00021MalfunctionAvailableexact di
2025-06-040002242056-2025-00024MalfunctionAvailableexact di
2025-06-040002242056-2025-00022MalfunctionAvailableexact di
2025-06-040002242056-2025-00023MalfunctionAvailableexact di
2025-06-040002242056-2025-00020MalfunctionAvailableexact di
2025-06-040002242056-2025-00019MalfunctionAvailableexact di
2025-05-130002242056-2025-00013MalfunctionAvailableexact di
2025-05-130002242056-2025-00014MalfunctionAvailableexact di
2025-05-130002242056-2025-00009MalfunctionAvailableexact di
2025-05-130002242056-2025-00010MalfunctionAvailableexact di
2025-05-130002242056-2025-00012MalfunctionAvailableexact di
2025-05-130002242056-2025-00011MalfunctionAvailableexact di
2025-05-060002242056-2025-00008MalfunctionAvailableexact di
2024-10-280002242056-2024-00030MalfunctionAvailableexact di
2022-10-140002242056-2022-00009MalfunctionAvailableexact di

Showing the most recent 18 of 20 linked reports.

Showing 1–15 of 18
Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2011-05-17NAINo action indicatedA&E Medical Corp0
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