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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.

28 linked reportsMalfunction 28
81624332019-01: 0 reports for this device; peer average 1/device2019-03: 0 reports for this device; peer average 2.75/device2019-04: 0 reports for this device; peer average 5.5/device2019-05: 0 reports for this device; peer average 2.5/device2019-06: 0 reports for this device; peer average 2/device2019-07: 0 reports for this device; peer average 3.8/device2019-08: 0 reports for this device; peer average 2.75/device2019-09: 0 reports for this device; peer average 2.75/device2019-10: 0 reports for this device; peer average 1.67/device2019-11: 0 reports for this device; peer average 1/device2019-12: 0 reports for this device; peer average 1.33/device2020-01: 0 reports for this device; peer average 2/device2020-02: 0 reports for this device; peer average 4/device2020-03: 0 reports for this device; peer average 2.78/device2020-04: 0 reports for this device; peer average 2/device2020-05: 0 reports for this device; peer average 2/device2020-06: 0 reports for this device; peer average 1.5/device2020-07: 0 reports for this device; peer average 32.5/device2020-08: 0 reports for this device; peer average 2.57/device2020-09: 0 reports for this device; peer average 2/device2020-10: 0 reports for this device; peer average 4.67/device2020-11: 0 reports for this device; peer average 1/device2020-12: 0 reports for this device; peer average 1.25/device2021-02: 0 reports for this device; peer average 4/device2021-03: 0 reports for this device; peer average 4.29/device2021-04: 0 reports for this device; peer average 2.33/device2021-05: 0 reports for this device; peer average 1.5/device2021-06: 0 reports for this device; peer average 2/device2021-07: 0 reports for this device; peer average 1.67/device2021-08: 0 reports for this device; peer average 2/device2021-09: 0 reports for this device; peer average 3/device2021-10: 0 reports for this device; peer average 1.5/device2021-11: 0 reports for this device; peer average 1/device2021-12: 0 reports for this device; peer average 1.5/device2022-01: 0 reports for this device; peer average 2.5/device2022-02: 0 reports for this device; peer average 3/device2022-03: 0 reports for this device; peer average 1/device2022-04: 0 reports for this device; peer average 2.38/device2022-05: 0 reports for this device; peer average 2.11/device2022-06: 0 reports for this device; peer average 2.92/device2022-07: 0 reports for this device; peer average 11/device2022-08: 0 reports for this device; peer average 2.25/device2022-09: 0 reports for this device; peer average 2.67/device2022-10: 0 reports for this device; peer average 1.67/device2022-11: 0 reports for this device; peer average 2.11/device2022-12: 0 reports for this device; peer average 1.67/device2023-01: 0 reports for this device; peer average 4.33/device2023-02: 0 reports for this device; peer average 2.33/device2023-03: 0 reports for this device; peer average 2/device2023-04: 0 reports for this device; peer average 2.78/device2023-05: 0 reports for this device; peer average 1.9/device2023-06: 0 reports for this device; peer average 1.56/device2023-07: 0 reports for this device; peer average 1.4/device2023-08: 0 reports for this device; peer average 3.33/device2023-09: 0 reports for this device; peer average 4/device2023-10: 0 reports for this device; peer average 1.5/device2023-11: 0 reports for this device; peer average 2.33/device2023-12: 0 reports for this device; peer average 2/device2024-01: 0 reports for this device; peer average 1.38/device2024-02: 0 reports for this device; peer average 22.75/device2024-03: 1 reports for this device; peer average 3.33/device2024-04: 0 reports for this device; peer average 4/device2024-05: 0 reports for this device; peer average 1.25/device2024-06: 0 reports for this device; peer average 3.5/device2024-07: 3 reports for this device; peer average 4.2/device2024-08: 12 reports for this device; peer average 5.4/device2024-09: 9 reports for this device; peer average 3.22/device2024-10: 0 reports for this device; peer average 2/device2024-11: 0 reports for this device; peer average 1.86/device2024-12: 0 reports for this device; peer average 2.67/device2025-01: 0 reports for this device; peer average 2.67/device2025-02: 0 reports for this device; peer average 6.75/device2025-03: 0 reports for this device; peer average 3.4/device2025-04: 0 reports for this device; peer average 4/device2025-05: 0 reports for this device; peer average 6.5/device2025-06: 0 reports for this device; peer average 3.33/device2025-07: 0 reports for this device; peer average 3/device2025-08: 0 reports for this device; peer average 4.5/device2025-09: 0 reports for this device; peer average 2/device2025-10: 0 reports for this device; peer average 1.5/device2025-11: 0 reports for this device; peer average 2/device2025-12: 0 reports for this device; peer average 4.5/device2026-01: 0 reports for this device; peer average 3.5/device2026-02: 0 reports for this device; peer average 4.33/device2026-03: 0 reports for this device; peer average 1.67/device2026-04: 0 reports for this device; peer average 2.67/device2026-05: 0 reports for this device; peer average 2/device2026-06: 3 reports for this device; peer average 2.2/device01030405060708091011120102030405060708091011120203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101
2019-0302.75
2019-0405.5
2019-0502.5
2019-0602
2019-0703.8
2019-0802.75
2019-0902.75
2019-1001.67
2019-1101
2019-1201.33
2020-0102
2020-0204
2020-0302.78
2020-0402
2020-0502
2020-0601.5
2020-07032.5
2020-0802.57
2020-0902
2020-1004.67
2020-1101
2020-1201.25
2021-0204
2021-0304.29
2021-0402.33
2021-0501.5
2021-0602
2021-0701.67
2021-0802
2021-0903
2021-1001.5
2021-1101
2021-1201.5
2022-0102.5
2022-0203
2022-0301
2022-0402.38
2022-0502.11
2022-0602.92
2022-07011
2022-0802.25
2022-0902.67
2022-1001.67
2022-1102.11
2022-1201.67
2023-0104.33
2023-0202.33
2023-0302
2023-0402.78
2023-0501.9
2023-0601.56
2023-0701.4
2023-0803.33
2023-0904
2023-1001.5
2023-1102.33
2023-1202
2024-0101.38
2024-02022.75
2024-0313.33
2024-0404
2024-0501.25
2024-0603.5
2024-0734.2
2024-08125.4
2024-0993.22
2024-1002
2024-1101.86
2024-1202.67
2025-0102.67
2025-0206.75
2025-0303.4
2025-0404
2025-0506.5
2025-0603.33
2025-0703
2025-0804.5
2025-0902
2025-1001.5
2025-1102
2025-1204.5
2026-0103.5
2026-0204.33
2026-0301.67
2026-0402.67
2026-0502
2026-0632.2
This device (reports/month)Average device in KDQ (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2026-06-191528319-2026-00071Malfunction—catalog number
2024-09-261528319-2024-00078MalfunctionAvailablecatalog number
2024-09-191528319-2024-00076MalfunctionAvailablecatalog number
2024-09-181528319-2024-00075MalfunctionAvailablecatalog number
2024-08-291528319-2024-00072MalfunctionAvailablecatalog number
2024-08-291528319-2024-00071MalfunctionAvailablecatalog number
2024-08-221528319-2024-00068MalfunctionAvailablecatalog number
2024-08-221528319-2024-00069MalfunctionAvailablecatalog number
2024-07-171528319-2024-00060MalfunctionAvailablecatalog number
2024-03-201528319-2024-00020MalfunctionAvailableexact di

Showing the most recent 10 of 28 linked reports.

Regulatory clearances

None linked.

Manufacturer compliance record

None in the loaded window.

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