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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 65
369132019-01: 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/device2019-04: 0 reports for this device; peer average 4.5/device2019-06: 0 reports for this device; peer average 1/device2019-07: 0 reports for this device; peer average 1/device2019-08: 0 reports for this device; peer average 4/device2019-09: 0 reports for this device; peer average 1.75/device2019-10: 0 reports for this device; peer average 1.5/device2019-11: 0 reports for this device; peer average 8/device2019-12: 0 reports for this device; peer average 4/device2020-01: 0 reports for this device; peer average 1.75/device2020-02: 0 reports for this device; peer average 4.67/device2020-03: 0 reports for this device; peer average 3/device2020-04: 0 reports for this device; peer average 1/device2020-06: 0 reports for this device; peer average 1/device2020-07: 0 reports for this device; peer average 1/device2020-08: 0 reports for this device; peer average 2/device2020-09: 0 reports for this device; peer average 3/device2020-10: 0 reports for this device; peer average 3.25/device2020-11: 0 reports for this device; peer average 2/device2020-12: 1 reports for this device; peer average 3.2/device2021-01: 1 reports for this device; peer average 2/device2021-02: 1 reports for this device; peer average 1/device2021-03: 0 reports for this device; peer average 2/device2021-04: 0 reports for this device; peer average 1.5/device2021-05: 0 reports for this device; peer average 2.5/device2021-06: 0 reports for this device; peer average 1/device2021-07: 0 reports for this device; peer average 2/device2021-08: 0 reports for this device; peer average 2/device2021-09: 0 reports for this device; peer average 1.5/device2021-10: 0 reports for this device; peer average 4.67/device2021-11: 0 reports for this device; peer average 1.67/device2021-12: 0 reports for this device; peer average 1.67/device2022-01: 3 reports for this device; peer average 3.75/device2022-02: 1 reports for this device; peer average 5/device2022-03: 1 reports for this device; peer average 5/device2022-04: 1 reports for this device; peer average 2.33/device2022-05: 0 reports for this device; peer average 3/device2022-06: 0 reports for this device; peer average 1.8/device2022-07: 3 reports for this device; peer average 2.6/device2022-08: 0 reports for this device; peer average 5/device2022-09: 0 reports for this device; peer average 4/device2022-10: 0 reports for this device; peer average 2.8/device2022-11: 1 reports for this device; peer average 1.33/device2022-12: 0 reports for this device; peer average 4.25/device2023-01: 0 reports for this device; peer average 1.67/device2023-02: 3 reports for this device; peer average 2.17/device2023-03: 1 reports for this device; peer average 1.83/device2023-04: 3 reports for this device; peer average 1.75/device2023-05: 2 reports for this device; peer average 2/device2023-06: 1 reports for this device; peer average 3.5/device2023-07: 2 reports for this device; peer average 2/device2023-08: 3 reports for this device; peer average 2/device2023-09: 0 reports for this device; peer average 1.67/device2023-10: 0 reports for this device; peer average 1.33/device2023-11: 0 reports for this device; peer average 2.5/device2023-12: 0 reports for this device; peer average 3/device2024-01: 3 reports for this device; peer average 2.67/device2024-02: 1 reports for this device; peer average 2.75/device2024-03: 0 reports for this device; peer average 3.8/device2024-04: 0 reports for this device; peer average 4.5/device2024-05: 0 reports for this device; peer average 1.33/device2024-06: 0 reports for this device; peer average 3.2/device2024-07: 6 reports for this device; peer average 3.33/device2024-08: 3 reports for this device; peer average 1.67/device2024-09: 0 reports for this device; peer average 5/device2024-10: 0 reports for this device; peer average 2/device2024-11: 3 reports for this device; peer average 2.83/device2024-12: 0 reports for this device; peer average 3/device2025-01: 0 reports for this device; peer average 10/device2025-02: 0 reports for this device; peer average 12.5/device2025-03: 4 reports for this device; peer average 8.33/device2025-04: 3 reports for this device; peer average 6.5/device2025-05: 0 reports for this device; peer average 11.75/device2025-06: 0 reports for this device; peer average 12/device2025-07: 0 reports for this device; peer average 5.25/device2025-08: 0 reports for this device; peer average 10/device2025-09: 0 reports for this device; peer average 7/device2025-10: 3 reports for this device; peer average 9/device2025-11: 0 reports for this device; peer average 10/device2025-12: 0 reports for this device; peer average 10.33/device2026-01: 0 reports for this device; peer average 5.75/device2026-02: 0 reports for this device; peer average 5.33/device2026-03: 0 reports for this device; peer average 11.5/device2026-04: 2 reports for this device; peer average 4/device2026-05: 9 reports for this device; peer average 11.67/device2026-06: 0 reports for this device; peer average 6.8/device01020304060708091011120102030406070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
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
2019-0404.5
2019-0601
2019-0701
2019-0804
2019-0901.75
2019-1001.5
2019-1108
2019-1204
2020-0101.75
2020-0204.67
2020-0303
2020-0401
2020-0601
2020-0701
2020-0802
2020-0903
2020-1003.25
2020-1102
2020-1213.2
2021-0112
2021-0211
2021-0302
2021-0401.5
2021-0502.5
2021-0601
2021-0702
2021-0802
2021-0901.5
2021-1004.67
2021-1101.67
2021-1201.67
2022-0133.75
2022-0215
2022-0315
2022-0412.33
2022-0503
2022-0601.8
2022-0732.6
2022-0805
2022-0904
2022-1002.8
2022-1111.33
2022-1204.25
2023-0101.67
2023-0232.17
2023-0311.83
2023-0431.75
2023-0522
2023-0613.5
2023-0722
2023-0832
2023-0901.67
2023-1001.33
2023-1102.5
2023-1203
2024-0132.67
2024-0212.75
2024-0303.8
2024-0404.5
2024-0501.33
2024-0603.2
2024-0763.33
2024-0831.67
2024-0905
2024-1002
2024-1132.83
2024-1203
2025-01010
2025-02012.5
2025-0348.33
2025-0436.5
2025-05011.75
2025-06012
2025-0705.25
2025-08010
2025-0907
2025-1039
2025-11010
2025-12010.33
2026-0105.75
2026-0205.33
2026-03011.5
2026-0424
2026-05911.67
2026-0606.8
This device (reports/month)Average device in FGX (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
2026-05-281528319-2026-00062MalfunctionAvailablecatalog number
2026-05-151528319-2026-00050MalfunctionAvailablecatalog number
2026-05-061528319-2026-00046MalfunctionAvailablecatalog number
2026-04-1524884612MalfunctionAvailablecatalog number
2025-10-311528319-2025-00102MalfunctionAvailablecatalog number
2025-04-171528319-2025-00034MalfunctionAvailablecatalog number
2025-03-211528319-2025-00019MalfunctionAvailableexact di
2025-03-1821630663MalfunctionAvailablecatalog number
2024-11-201528319-2024-00103MalfunctionAvailablecatalog number
2024-08-091528319-2024-00065MalfunctionAvailablecatalog number
2024-07-261528319-2024-00064MalfunctionAvailablecatalog number
2024-07-181528319-2024-00062MalfunctionAvailablecatalog number
2024-02-231528319-2024-00012MalfunctionAvailableexact di
2024-01-291528319-2024-00006MalfunctionAvailableexact di
2024-01-2618586378MalfunctionAvailablecatalog number

Showing the most recent 38 of 65 linked reports.

Showing 1–15 of 38
Regulatory clearances

None linked.

Manufacturer compliance record

None in the loaded window.

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