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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.

39 linked reportsMalfunction 39
4913182019-01: 0 reports for this device; peer average 2.92/device2019-02: 0 reports for this device; peer average 3.83/device2019-03: 1 reports for this device; peer average 3.38/device2019-04: 0 reports for this device; peer average 3.19/device2019-05: 1 reports for this device; peer average 4/device2019-06: 1 reports for this device; peer average 3.22/device2019-07: 3 reports for this device; peer average 3.63/device2019-08: 0 reports for this device; peer average 4.08/device2019-09: 2 reports for this device; peer average 4.22/device2019-10: 3 reports for this device; peer average 3.43/device2019-11: 1 reports for this device; peer average 3.02/device2019-12: 2 reports for this device; peer average 2.8/device2020-01: 0 reports for this device; peer average 3.15/device2020-02: 0 reports for this device; peer average 3.53/device2020-03: 1 reports for this device; peer average 2.95/device2020-04: 1 reports for this device; peer average 3.45/device2020-05: 1 reports for this device; peer average 3.28/device2020-06: 1 reports for this device; peer average 2.64/device2020-07: 3 reports for this device; peer average 3.24/device2020-08: 0 reports for this device; peer average 3.24/device2020-09: 1 reports for this device; peer average 4.05/device2020-10: 1 reports for this device; peer average 3.82/device2020-11: 1 reports for this device; peer average 3.28/device2020-12: 0 reports for this device; peer average 3.2/device2021-01: 0 reports for this device; peer average 2.43/device2021-02: 2 reports for this device; peer average 3.32/device2021-03: 1 reports for this device; peer average 2.96/device2021-04: 0 reports for this device; peer average 3.05/device2021-05: 1 reports for this device; peer average 2.16/device2021-06: 1 reports for this device; peer average 2.31/device2021-07: 1 reports for this device; peer average 3.09/device2021-08: 0 reports for this device; peer average 3.13/device2021-09: 2 reports for this device; peer average 3.57/device2021-10: 0 reports for this device; peer average 2.55/device2021-11: 0 reports for this device; peer average 2.37/device2021-12: 0 reports for this device; peer average 2.31/device2022-01: 0 reports for this device; peer average 2.27/device2022-02: 0 reports for this device; peer average 2.81/device2022-03: 2 reports for this device; peer average 2.62/device2022-04: 1 reports for this device; peer average 2.31/device2022-05: 0 reports for this device; peer average 2.47/device2022-06: 0 reports for this device; peer average 2.58/device2022-07: 0 reports for this device; peer average 2.56/device2022-08: 0 reports for this device; peer average 2.65/device2022-09: 0 reports for this device; peer average 2.55/device2022-10: 0 reports for this device; peer average 2.69/device2022-11: 0 reports for this device; peer average 4.2/device2022-12: 0 reports for this device; peer average 3.19/device2023-01: 0 reports for this device; peer average 4.29/device2023-02: 0 reports for this device; peer average 4.73/device2023-03: 0 reports for this device; peer average 5.6/device2023-04: 0 reports for this device; peer average 4.98/device2023-05: 0 reports for this device; peer average 5/device2023-06: 0 reports for this device; peer average 5.14/device2023-07: 0 reports for this device; peer average 6.02/device2023-08: 3 reports for this device; peer average 5.7/device2023-09: 1 reports for this device; peer average 5.14/device2023-10: 0 reports for this device; peer average 4.48/device2023-11: 0 reports for this device; peer average 3.85/device2023-12: 0 reports for this device; peer average 5.61/device2024-01: 0 reports for this device; peer average 4.24/device2024-02: 0 reports for this device; peer average 7.28/device2024-03: 0 reports for this device; peer average 8.65/device2024-04: 0 reports for this device; peer average 13.36/device2024-05: 0 reports for this device; peer average 17.87/device2024-06: 0 reports for this device; peer average 16.58/device2024-07: 0 reports for this device; peer average 13.72/device2024-08: 0 reports for this device; peer average 9.31/device2024-09: 0 reports for this device; peer average 7.24/device2024-10: 0 reports for this device; peer average 5.47/device2024-11: 0 reports for this device; peer average 3.94/device2024-12: 0 reports for this device; peer average 4.21/device2025-01: 0 reports for this device; peer average 2.94/device2025-02: 0 reports for this device; peer average 2.37/device2025-03: 0 reports for this device; peer average 2.97/device2025-04: 0 reports for this device; peer average 3.33/device2025-05: 0 reports for this device; peer average 2.84/device2025-06: 0 reports for this device; peer average 4.16/device2025-07: 0 reports for this device; peer average 2.88/device2025-08: 0 reports for this device; peer average 2.85/device2025-09: 0 reports for this device; peer average 2.66/device2025-10: 0 reports for this device; peer average 3.28/device2025-11: 0 reports for this device; peer average 3.18/device2025-12: 0 reports for this device; peer average 2.47/device2026-01: 0 reports for this device; peer average 2.95/device2026-02: 0 reports for this device; peer average 3.78/device2026-03: 0 reports for this device; peer average 2.97/device2026-04: 0 reports for this device; peer average 2.86/device2026-05: 0 reports for this device; peer average 2.87/device2026-06: 0 reports for this device; peer average 3.59/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.92
2019-0203.83
2019-0313.38
2019-0403.19
2019-0514
2019-0613.22
2019-0733.63
2019-0804.08
2019-0924.22
2019-1033.43
2019-1113.02
2019-1222.8
2020-0103.15
2020-0203.53
2020-0312.95
2020-0413.45
2020-0513.28
2020-0612.64
2020-0733.24
2020-0803.24
2020-0914.05
2020-1013.82
2020-1113.28
2020-1203.2
2021-0102.43
2021-0223.32
2021-0312.96
2021-0403.05
2021-0512.16
2021-0612.31
2021-0713.09
2021-0803.13
2021-0923.57
2021-1002.55
2021-1102.37
2021-1202.31
2022-0102.27
2022-0202.81
2022-0322.62
2022-0412.31
2022-0502.47
2022-0602.58
2022-0702.56
2022-0802.65
2022-0902.55
2022-1002.69
2022-1104.2
2022-1203.19
2023-0104.29
2023-0204.73
2023-0305.6
2023-0404.98
2023-0505
2023-0605.14
2023-0706.02
2023-0835.7
2023-0915.14
2023-1004.48
2023-1103.85
2023-1205.61
2024-0104.24
2024-0207.28
2024-0308.65
2024-04013.36
2024-05017.87
2024-06016.58
2024-07013.72
2024-0809.31
2024-0907.24
2024-1005.47
2024-1103.94
2024-1204.21
2025-0102.94
2025-0202.37
2025-0302.97
2025-0403.33
2025-0502.84
2025-0604.16
2025-0702.88
2025-0802.85
2025-0902.66
2025-1003.28
2025-1103.18
2025-1202.47
2026-0102.95
2026-0203.78
2026-0302.97
2026-0402.86
2026-0502.87
2026-0603.59
This device (reports/month)Average device in FMF (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2023-09-191920898-2023-00635MalfunctionAvailableexact di
2023-08-281920898-2023-00584MalfunctionAvailableexact di
2023-08-141920898-2023-00558MalfunctionAvailableexact di
2023-08-081920898-2023-00537MalfunctionAvailableexact di
2022-04-211920898-2022-00262MalfunctionAvailableexact di
2022-03-251920898-2022-00194MalfunctionAvailableexact di
2022-03-041920898-2022-00145MalfunctionAvailableexact di
2021-09-291920898-2021-01029MalfunctionAvailableexact di
2021-09-141920898-2021-00989MalfunctionAvailableexact di
2021-07-271920898-2021-00814MalfunctionAvailableexact di
2021-06-211920898-2021-00674MalfunctionAvailableexact di
2021-05-141920898-2021-00556MalfunctionAvailableexact di
2021-03-221920898-2021-00335MalfunctionAvailableexact di
2021-02-181920898-2021-00196MalfunctionAvailableexact di
2021-02-081920898-2021-00162MalfunctionAvailableexact di
Showing 1–15 of 39
Regulatory clearances

None linked.

Manufacturer compliance record

None in the loaded window.

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