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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.

2 linked reportsMalfunction 2
25792019-01: 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/device2019-05: 0 reports for this device; peer average 2.5/device2019-06: 0 reports for this device; peer average 4/device2019-07: 0 reports for this device; peer average 1.75/device2019-08: 0 reports for this device; peer average 1.75/device2019-09: 0 reports for this device; peer average 2.67/device2019-10: 0 reports for this device; peer average 2.6/device2019-11: 0 reports for this device; peer average 2/device2019-12: 0 reports for this device; peer average 2.33/device2020-01: 0 reports for this device; peer average 4.67/device2020-02: 0 reports for this device; peer average 3/device2020-03: 0 reports for this device; peer average 1.67/device2020-04: 0 reports for this device; peer average 2.5/device2020-05: 0 reports for this device; peer average 1.5/device2020-06: 0 reports for this device; peer average 2.2/device2020-07: 0 reports for this device; peer average 6.5/device2020-09: 0 reports for this device; peer average 2/device2020-10: 0 reports for this device; peer average 9/device2020-11: 0 reports for this device; peer average 8.5/device2020-12: 0 reports for this device; peer average 5.67/device2021-01: 0 reports for this device; peer average 2.33/device2021-02: 0 reports for this device; peer average 3.67/device2021-03: 0 reports for this device; peer average 3.71/device2021-04: 0 reports for this device; peer average 3/device2021-05: 2 reports for this device; peer average 2/device2021-06: 0 reports for this device; peer average 4/device2021-07: 0 reports for this device; peer average 3/device2021-08: 0 reports for this device; peer average 1.83/device2021-09: 0 reports for this device; peer average 1.5/device2021-10: 0 reports for this device; peer average 7.5/device2021-12: 0 reports for this device; peer average 6/device2022-01: 0 reports for this device; peer average 9/device2022-02: 0 reports for this device; peer average 2/device2022-03: 0 reports for this device; peer average 3/device2022-05: 0 reports for this device; peer average 2.25/device2022-06: 0 reports for this device; peer average 2.67/device2022-08: 0 reports for this device; peer average 3/device2022-09: 0 reports for this device; peer average 3/device2022-10: 0 reports for this device; peer average 3.25/device2022-11: 0 reports for this device; peer average 3/device2022-12: 0 reports for this device; peer average 1/device2023-02: 0 reports for this device; peer average 3/device2023-03: 0 reports for this device; peer average 2/device2023-04: 0 reports for this device; peer average 1/device2023-05: 0 reports for this device; peer average 1.86/device2023-06: 0 reports for this device; peer average 1.67/device2023-07: 0 reports for this device; peer average 1.67/device2023-08: 0 reports for this device; peer average 1/device2023-09: 0 reports for this device; peer average 2/device2023-10: 0 reports for this device; peer average 1.8/device2023-11: 0 reports for this device; peer average 4.33/device2023-12: 0 reports for this device; peer average 4.5/device2024-01: 0 reports for this device; peer average 3/device2024-02: 0 reports for this device; peer average 2/device2024-03: 0 reports for this device; peer average 2.4/device2024-04: 0 reports for this device; peer average 5/device2024-05: 0 reports for this device; peer average 2/device2024-07: 0 reports for this device; peer average 2.5/device2024-09: 0 reports for this device; peer average 3/device2024-10: 0 reports for this device; peer average 1/device2024-11: 0 reports for this device; peer average 2.33/device2024-12: 0 reports for this device; peer average 2.75/device2025-01: 0 reports for this device; peer average 2.25/device2025-02: 0 reports for this device; peer average 2/device2025-03: 0 reports for this device; peer average 2.5/device2025-05: 0 reports for this device; peer average 3/device2025-06: 0 reports for this device; peer average 2.78/device2025-07: 0 reports for this device; peer average 2.4/device2025-08: 0 reports for this device; peer average 2.6/device2025-09: 0 reports for this device; peer average 2.6/device2025-10: 0 reports for this device; peer average 2/device2025-11: 0 reports for this device; peer average 3.25/device2025-12: 0 reports for this device; peer average 1.63/device2026-01: 0 reports for this device; peer average 2/device2026-02: 0 reports for this device; peer average 3/device2026-03: 0 reports for this device; peer average 2.78/device2026-04: 0 reports for this device; peer average 2.33/device2026-05: 0 reports for this device; peer average 2.4/device2026-06: 0 reports for this device; peer average 1/device01020304050607080910111201020304050607091011120102030405060708091012010203050608091011120203040506070809101112010203040507091011120102030506070809101112010203040506
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
2019-0502.5
2019-0604
2019-0701.75
2019-0801.75
2019-0902.67
2019-1002.6
2019-1102
2019-1202.33
2020-0104.67
2020-0203
2020-0301.67
2020-0402.5
2020-0501.5
2020-0602.2
2020-0706.5
2020-0902
2020-1009
2020-1108.5
2020-1205.67
2021-0102.33
2021-0203.67
2021-0303.71
2021-0403
2021-0522
2021-0604
2021-0703
2021-0801.83
2021-0901.5
2021-1007.5
2021-1206
2022-0109
2022-0202
2022-0303
2022-0502.25
2022-0602.67
2022-0803
2022-0903
2022-1003.25
2022-1103
2022-1201
2023-0203
2023-0302
2023-0401
2023-0501.86
2023-0601.67
2023-0701.67
2023-0801
2023-0902
2023-1001.8
2023-1104.33
2023-1204.5
2024-0103
2024-0202
2024-0302.4
2024-0405
2024-0502
2024-0702.5
2024-0903
2024-1001
2024-1102.33
2024-1202.75
2025-0102.25
2025-0202
2025-0302.5
2025-0503
2025-0602.78
2025-0702.4
2025-0802.6
2025-0902.6
2025-1002
2025-1103.25
2025-1201.63
2026-0102
2026-0203
2026-0302.78
2026-0402.33
2026-0502.4
2026-0601
This device (reports/month)Average device in CAT (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2021-05-133004604967-2021-00593MalfunctionAvailableexact di
2021-05-133007573469-2021-00593MalfunctionAvailableexact di
Regulatory clearances

None linked.

Manufacturer compliance record

None in the loaded window.

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