Skip to content
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.

34 linked reportsInjury 34
13462019-01: 0 reports for this device; peer average 1.38/device2019-02: 0 reports for this device; peer average 2.07/device2019-03: 0 reports for this device; peer average 1.86/device2019-04: 0 reports for this device; peer average 1.8/device2019-05: 0 reports for this device; peer average 2.52/device2019-06: 0 reports for this device; peer average 1.81/device2019-07: 0 reports for this device; peer average 2.87/device2019-08: 0 reports for this device; peer average 2.39/device2019-09: 0 reports for this device; peer average 2.16/device2019-10: 0 reports for this device; peer average 2.25/device2019-11: 0 reports for this device; peer average 1.76/device2019-12: 0 reports for this device; peer average 1.96/device2020-01: 0 reports for this device; peer average 2.51/device2020-02: 0 reports for this device; peer average 2.24/device2020-03: 0 reports for this device; peer average 2.38/device2020-04: 0 reports for this device; peer average 1.71/device2020-05: 0 reports for this device; peer average 2.13/device2020-06: 0 reports for this device; peer average 2.92/device2020-07: 0 reports for this device; peer average 1.97/device2020-08: 0 reports for this device; peer average 2.47/device2020-09: 3 reports for this device; peer average 2.13/device2020-10: 0 reports for this device; peer average 2.37/device2020-11: 0 reports for this device; peer average 2.59/device2020-12: 2 reports for this device; peer average 2.07/device2021-01: 0 reports for this device; peer average 2.09/device2021-02: 2 reports for this device; peer average 2.25/device2021-03: 0 reports for this device; peer average 2.07/device2021-04: 3 reports for this device; peer average 3.48/device2021-05: 0 reports for this device; peer average 2.14/device2021-06: 0 reports for this device; peer average 2.22/device2021-07: 0 reports for this device; peer average 2.2/device2021-08: 0 reports for this device; peer average 2.39/device2021-09: 0 reports for this device; peer average 3.76/device2021-10: 0 reports for this device; peer average 3.29/device2021-11: 3 reports for this device; peer average 3.34/device2021-12: 0 reports for this device; peer average 4.77/device2022-01: 0 reports for this device; peer average 2.43/device2022-02: 0 reports for this device; peer average 2.09/device2022-03: 0 reports for this device; peer average 1.88/device2022-04: 0 reports for this device; peer average 1.84/device2022-05: 0 reports for this device; peer average 1.85/device2022-06: 3 reports for this device; peer average 2.07/device2022-07: 0 reports for this device; peer average 1.95/device2022-08: 3 reports for this device; peer average 2.16/device2022-09: 0 reports for this device; peer average 1.82/device2022-10: 0 reports for this device; peer average 2.64/device2022-11: 0 reports for this device; peer average 2.04/device2022-12: 0 reports for this device; peer average 2.33/device2023-01: 0 reports for this device; peer average 1.96/device2023-02: 0 reports for this device; peer average 2.4/device2023-03: 0 reports for this device; peer average 1.91/device2023-04: 0 reports for this device; peer average 2.09/device2023-05: 0 reports for this device; peer average 1.95/device2023-06: 0 reports for this device; peer average 2.06/device2023-07: 3 reports for this device; peer average 2/device2023-08: 0 reports for this device; peer average 2.32/device2023-09: 0 reports for this device; peer average 1.98/device2023-10: 0 reports for this device; peer average 2.02/device2023-11: 3 reports for this device; peer average 5.85/device2023-12: 0 reports for this device; peer average 2.78/device2024-01: 0 reports for this device; peer average 1.83/device2024-02: 0 reports for this device; peer average 1.93/device2024-03: 3 reports for this device; peer average 1.88/device2024-04: 0 reports for this device; peer average 2.01/device2024-05: 3 reports for this device; peer average 2.03/device2024-06: 0 reports for this device; peer average 1.82/device2024-07: 3 reports for this device; peer average 2.17/device2024-08: 0 reports for this device; peer average 1.84/device2024-09: 0 reports for this device; peer average 2.21/device2024-10: 0 reports for this device; peer average 2.08/device2024-11: 0 reports for this device; peer average 2.31/device2024-12: 0 reports for this device; peer average 2.14/device2025-01: 0 reports for this device; peer average 1.75/device2025-02: 0 reports for this device; peer average 2.61/device2025-03: 0 reports for this device; peer average 2.57/device2025-04: 0 reports for this device; peer average 2.4/device2025-05: 0 reports for this device; peer average 2.64/device2025-06: 0 reports for this device; peer average 2.82/device2025-07: 0 reports for this device; peer average 2.35/device2025-08: 0 reports for this device; peer average 1.95/device2025-09: 0 reports for this device; peer average 1.86/device2025-10: 0 reports for this device; peer average 2.57/device2025-11: 0 reports for this device; peer average 2.5/device2025-12: 0 reports for this device; peer average 2.67/device2026-01: 0 reports for this device; peer average 2.19/device2026-02: 0 reports for this device; peer average 2.52/device2026-03: 0 reports for this device; peer average 2.57/device2026-04: 0 reports for this device; peer average 1.95/device2026-05: 0 reports for this device; peer average 2.21/device2026-06: 0 reports for this device; peer average 1.92/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.38
2019-0202.07
2019-0301.86
2019-0401.8
2019-0502.52
2019-0601.81
2019-0702.87
2019-0802.39
2019-0902.16
2019-1002.25
2019-1101.76
2019-1201.96
2020-0102.51
2020-0202.24
2020-0302.38
2020-0401.71
2020-0502.13
2020-0602.92
2020-0701.97
2020-0802.47
2020-0932.13
2020-1002.37
2020-1102.59
2020-1222.07
2021-0102.09
2021-0222.25
2021-0302.07
2021-0433.48
2021-0502.14
2021-0602.22
2021-0702.2
2021-0802.39
2021-0903.76
2021-1003.29
2021-1133.34
2021-1204.77
2022-0102.43
2022-0202.09
2022-0301.88
2022-0401.84
2022-0501.85
2022-0632.07
2022-0701.95
2022-0832.16
2022-0901.82
2022-1002.64
2022-1102.04
2022-1202.33
2023-0101.96
2023-0202.4
2023-0301.91
2023-0402.09
2023-0501.95
2023-0602.06
2023-0732
2023-0802.32
2023-0901.98
2023-1002.02
2023-1135.85
2023-1202.78
2024-0101.83
2024-0201.93
2024-0331.88
2024-0402.01
2024-0532.03
2024-0601.82
2024-0732.17
2024-0801.84
2024-0902.21
2024-1002.08
2024-1102.31
2024-1202.14
2025-0101.75
2025-0202.61
2025-0302.57
2025-0402.4
2025-0502.64
2025-0602.82
2025-0702.35
2025-0801.95
2025-0901.86
2025-1002.57
2025-1102.5
2025-1202.67
2026-0102.19
2026-0202.52
2026-0302.57
2026-0401.95
2026-0502.21
2026-0601.92
This device (reports/month)Average device in JXG (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2024-07-033004721439-2024-00187InjuryAvailablecatalog number
2024-05-013004721439-2024-00108InjuryAvailablecatalog number
2024-03-153004721439-2024-00068InjuryAvailablecatalog number
2023-11-013004721439-2023-00313InjuryAvailablecatalog number
2023-07-123004721439-2023-00187InjuryAvailablecatalog number
2022-08-253004721439-2022-00249InjuryAvailablecatalog number
2022-06-223004721439-2022-00174InjuryAvailablecatalog number
2021-11-073004721439-2021-00298InjuryAvailablecatalog number
2021-04-073004721439-2021-00065InjuryAvailablecatalog number
2021-02-163004721439-2021-00022InjuryAvailablecatalog number
2020-12-153004721439-2020-00258InjuryAvailablecatalog number
2020-09-173004721439-2020-00183InjuryAvailablecatalog number

Showing the most recent 12 of 34 linked reports.

Regulatory clearances

None linked.

Manufacturer compliance record

None in the loaded window.

Similar devices
Select up to two to place side-by-side with this device.