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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.

69 linked reportsMalfunction 69
4813172019-01: 0 reports for this device; peer average 1/device2019-02: 0 reports for this device; peer average 1.4/device2019-03: 0 reports for this device; peer average 1.5/device2019-04: 1 reports for this device; peer average 1.13/device2019-05: 0 reports for this device; peer average 1.33/device2019-06: 0 reports for this device; peer average 1.17/device2019-07: 0 reports for this device; peer average 1.5/device2019-08: 0 reports for this device; peer average 1/device2019-09: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 1.86/device2019-11: 0 reports for this device; peer average 1.33/device2019-12: 0 reports for this device; peer average 1/device2020-01: 0 reports for this device; peer average 1.25/device2020-02: 0 reports for this device; peer average 2.17/device2020-03: 0 reports for this device; peer average 2/device2020-04: 0 reports for this device; peer average 3/device2020-05: 1 reports for this device; peer average 1/device2020-06: 0 reports for this device; peer average 2.5/device2020-07: 2 reports for this device; peer average 1.33/device2020-09: 0 reports for this device; peer average 1.63/device2020-10: 0 reports for this device; peer average 2/device2020-11: 0 reports for this device; peer average 1.5/device2020-12: 0 reports for this device; peer average 1.2/device2021-01: 0 reports for this device; peer average 1/device2021-02: 0 reports for this device; peer average 2/device2021-03: 0 reports for this device; peer average 1.75/device2021-04: 0 reports for this device; peer average 2/device2021-05: 0 reports for this device; peer average 2/device2021-06: 2 reports for this device; peer average 2/device2021-07: 1 reports for this device; peer average 1.2/device2021-08: 0 reports for this device; peer average 1.5/device2021-09: 0 reports for this device; peer average 1/device2021-10: 1 reports for this device; peer average 1.33/device2021-11: 0 reports for this device; peer average 2.25/device2021-12: 0 reports for this device; peer average 1/device2022-02: 0 reports for this device; peer average 1.75/device2022-03: 2 reports for this device; peer average 2.5/device2022-04: 2 reports for this device; peer average 1.67/device2022-05: 3 reports for this device; peer average 2.5/device2022-06: 0 reports for this device; peer average 3.5/device2022-07: 0 reports for this device; peer average 2.67/device2022-08: 0 reports for this device; peer average 1.5/device2022-09: 1 reports for this device; peer average 1.75/device2022-10: 0 reports for this device; peer average 1.8/device2022-11: 0 reports for this device; peer average 2/device2022-12: 0 reports for this device; peer average 1.88/device2023-01: 0 reports for this device; peer average 1.75/device2023-02: 0 reports for this device; peer average 2/device2023-03: 0 reports for this device; peer average 2.5/device2023-04: 1 reports for this device; peer average 1.44/device2023-05: 1 reports for this device; peer average 1/device2023-06: 1 reports for this device; peer average 1/device2023-07: 1 reports for this device; peer average 1/device2023-08: 0 reports for this device; peer average 1/device2023-09: 0 reports for this device; peer average 4.33/device2023-10: 0 reports for this device; peer average 1.67/device2023-11: 2 reports for this device; peer average 1.5/device2023-12: 1 reports for this device; peer average 1.36/device2024-01: 0 reports for this device; peer average 1.75/device2024-02: 0 reports for this device; peer average 1.67/device2024-03: 0 reports for this device; peer average 2/device2024-04: 2 reports for this device; peer average 1.6/device2024-05: 0 reports for this device; peer average 1.25/device2024-06: 1 reports for this device; peer average 1.17/device2024-07: 1 reports for this device; peer average 1.22/device2024-08: 0 reports for this device; peer average 1.5/device2024-09: 2 reports for this device; peer average 1.6/device2024-10: 3 reports for this device; peer average 1.9/device2024-11: 2 reports for this device; peer average 5.55/device2024-12: 0 reports for this device; peer average 8.83/device2025-01: 0 reports for this device; peer average 1.5/device2025-02: 3 reports for this device; peer average 1.73/device2025-03: 6 reports for this device; peer average 2.91/device2025-04: 0 reports for this device; peer average 2/device2025-05: 0 reports for this device; peer average 16.67/device2025-06: 0 reports for this device; peer average 1/device2025-07: 0 reports for this device; peer average 4.33/device2025-08: 0 reports for this device; peer average 2/device2025-09: 0 reports for this device; peer average 1.86/device2025-11: 5 reports for this device; peer average 3.08/device2025-12: 3 reports for this device; peer average 2.2/device2026-01: 6 reports for this device; peer average 4/device2026-02: 0 reports for this device; peer average 2.5/device2026-03: 0 reports for this device; peer average 2.17/device2026-04: 11 reports for this device; peer average 6.25/device2026-05: 0 reports for this device; peer average 2.14/device2026-06: 1 reports for this device; peer average 2/device010203040506070809101112010203040506070910111201020304050607080910111202030405060708091011120102030405060708091011120102030405060708091011120102030405060708091112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101
2019-0201.4
2019-0301.5
2019-0411.13
2019-0501.33
2019-0601.17
2019-0701.5
2019-0801
2019-0901
2019-1001.86
2019-1101.33
2019-1201
2020-0101.25
2020-0202.17
2020-0302
2020-0403
2020-0511
2020-0602.5
2020-0721.33
2020-0901.63
2020-1002
2020-1101.5
2020-1201.2
2021-0101
2021-0202
2021-0301.75
2021-0402
2021-0502
2021-0622
2021-0711.2
2021-0801.5
2021-0901
2021-1011.33
2021-1102.25
2021-1201
2022-0201.75
2022-0322.5
2022-0421.67
2022-0532.5
2022-0603.5
2022-0702.67
2022-0801.5
2022-0911.75
2022-1001.8
2022-1102
2022-1201.88
2023-0101.75
2023-0202
2023-0302.5
2023-0411.44
2023-0511
2023-0611
2023-0711
2023-0801
2023-0904.33
2023-1001.67
2023-1121.5
2023-1211.36
2024-0101.75
2024-0201.67
2024-0302
2024-0421.6
2024-0501.25
2024-0611.17
2024-0711.22
2024-0801.5
2024-0921.6
2024-1031.9
2024-1125.55
2024-1208.83
2025-0101.5
2025-0231.73
2025-0362.91
2025-0402
2025-05016.67
2025-0601
2025-0704.33
2025-0802
2025-0901.86
2025-1153.08
2025-1232.2
2026-0164
2026-0202.5
2026-0302.17
2026-04116.25
2026-0502.14
2026-0612
This device (reports/month)Average device in OCZ, PTS (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2026-06-0525408783MalfunctionAvailableexact di
2026-04-301528319-2026-00042MalfunctionAvailablecatalog number
2026-04-291528319-2026-00040MalfunctionAvailablecatalog number
2026-04-291528319-2026-00041MalfunctionAvailablecatalog number
2026-04-281528319-2026-00039MalfunctionAvailablecatalog number
2026-01-251528319-2026-00003MalfunctionAvailablecatalog number
2026-01-151528319-2026-00002MalfunctionAvailablecatalog number
2025-12-111528319-2025-00113MalfunctionAvailablecatalog number
2025-11-281528319-2025-00109MalfunctionAvailablecatalog number
2025-11-1323542412MalfunctionAvailablecatalog number
2025-03-271528319-2025-00023MalfunctionAvailablecatalog number
2025-03-071528319-2025-00014MalfunctionAvailablecatalog number
2025-02-211528319-2025-00009MalfunctionAvailablecatalog number
2024-11-081528319-2024-00097MalfunctionAvailablecatalog number
2024-10-101528319-2024-00083MalfunctionAvailablecatalog number

Showing the most recent 40 of 69 linked reports.

Showing 1–15 of 40
Regulatory clearances

None linked.

Manufacturer compliance record

None in the loaded window.

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