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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.

32 linked reportsInjury 32
23562019-01: 0 reports for this device; peer average 1.38/device2019-02: 2 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: 4 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: 0 reports for this device; peer average 2.07/device2021-01: 0 reports for this device; peer average 2.09/device2021-02: 0 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: 2 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: 0 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: 0 reports for this device; peer average 2.07/device2022-07: 0 reports for this device; peer average 1.95/device2022-08: 0 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: 3 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: 0 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: 0 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: 0 reports for this device; peer average 2.17/device2024-08: 0 reports for this device; peer average 1.84/device2024-09: 6 reports for this device; peer average 2.21/device2024-10: 3 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
2019-0222.07
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
2020-0342.38
2020-0401.71
2020-0502.13
2020-0602.92
2020-0701.97
2020-0802.47
2020-0932.13
2020-1002.37
2020-1102.59
2020-1202.07
2021-0102.09
2021-0202.25
2021-0302.07
2021-0433.48
2021-0522.14
2021-0602.22
2021-0702.2
2021-0802.39
2021-0903.76
2021-1003.29
2021-1103.34
2021-1204.77
2022-0102.43
2022-0202.09
2022-0301.88
2022-0401.84
2022-0501.85
2022-0602.07
2022-0701.95
2022-0802.16
2022-0901.82
2022-1002.64
2022-1102.04
2022-1202.33
2023-0131.96
2023-0202.4
2023-0301.91
2023-0402.09
2023-0501.95
2023-0602.06
2023-0702
2023-0802.32
2023-0901.98
2023-1002.02
2023-1105.85
2023-1202.78
2024-0101.83
2024-0201.93
2024-0331.88
2024-0402.01
2024-0532.03
2024-0601.82
2024-0702.17
2024-0801.84
2024-0962.21
2024-1032.08
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

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2024-10-113004721439-2024-00317InjuryAvailablecatalog number
2024-09-183004721439-2024-00289InjuryAvailablecatalog number
2024-09-163004721439-2024-00281InjuryAvailablecatalog number
2024-05-283004721439-2024-00153InjuryAvailablecatalog number
2024-03-253004721439-2024-00060InjuryAvailablecatalog number
2023-01-273004721439-2022-00436InjuryAvailablecatalog number
2021-05-193004721439-2021-00133InjuryAvailablecatalog number
2021-04-093004721439-2021-00074InjuryAvailablecatalog number
2020-09-143004721439-2020-00185InjuryAvailablecatalog number
2020-03-193004721439-2020-00067InjuryAvailablecatalog number
2020-03-133004721439-2020-00061InjuryAvailablecatalog number
2019-02-153004721439-2019-00035InjuryAvailablecatalog number

Showing the most recent 12 of 32 linked reports.

Regulatory clearances

None linked.

Manufacturer compliance record

None in the loaded window.

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