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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
122335472019-01: 1 reports for this device; peer average 5.06/device2019-02: 0 reports for this device; peer average 4.07/device2019-03: 0 reports for this device; peer average 4.63/device2019-04: 0 reports for this device; peer average 4.62/device2019-05: 0 reports for this device; peer average 4.69/device2019-06: 0 reports for this device; peer average 4.3/device2019-07: 0 reports for this device; peer average 5/device2019-08: 0 reports for this device; peer average 6.17/device2019-09: 0 reports for this device; peer average 5.48/device2019-10: 0 reports for this device; peer average 5.14/device2019-11: 3 reports for this device; peer average 7.13/device2019-12: 0 reports for this device; peer average 6.59/device2020-01: 0 reports for this device; peer average 6.93/device2020-02: 0 reports for this device; peer average 5.15/device2020-03: 4 reports for this device; peer average 6.97/device2020-04: 0 reports for this device; peer average 8.85/device2020-05: 0 reports for this device; peer average 7.63/device2020-06: 1 reports for this device; peer average 6.74/device2020-07: 0 reports for this device; peer average 6.71/device2020-08: 0 reports for this device; peer average 6.78/device2020-09: 0 reports for this device; peer average 6.02/device2020-10: 0 reports for this device; peer average 7.39/device2020-11: 0 reports for this device; peer average 8.82/device2020-12: 0 reports for this device; peer average 9.67/device2021-01: 0 reports for this device; peer average 9.29/device2021-02: 0 reports for this device; peer average 9.91/device2021-03: 0 reports for this device; peer average 8.62/device2021-04: 0 reports for this device; peer average 8.69/device2021-05: 0 reports for this device; peer average 7.86/device2021-06: 0 reports for this device; peer average 6.39/device2021-07: 0 reports for this device; peer average 8.38/device2021-08: 0 reports for this device; peer average 6.93/device2021-09: 0 reports for this device; peer average 7.23/device2021-10: 2 reports for this device; peer average 7.79/device2021-11: 0 reports for this device; peer average 8.31/device2021-12: 0 reports for this device; peer average 8.71/device2022-01: 0 reports for this device; peer average 6.9/device2022-02: 0 reports for this device; peer average 7.45/device2022-03: 0 reports for this device; peer average 8.41/device2022-04: 0 reports for this device; peer average 6.2/device2022-05: 0 reports for this device; peer average 7.71/device2022-06: 0 reports for this device; peer average 6.51/device2022-07: 0 reports for this device; peer average 6.39/device2022-08: 0 reports for this device; peer average 9/device2022-09: 0 reports for this device; peer average 7.01/device2022-10: 0 reports for this device; peer average 8.23/device2022-11: 0 reports for this device; peer average 9.39/device2022-12: 0 reports for this device; peer average 8.84/device2023-01: 0 reports for this device; peer average 9.38/device2023-02: 0 reports for this device; peer average 9.48/device2023-03: 1 reports for this device; peer average 11.29/device2023-04: 0 reports for this device; peer average 11.77/device2023-05: 0 reports for this device; peer average 11.2/device2023-06: 0 reports for this device; peer average 12.06/device2023-07: 0 reports for this device; peer average 13.11/device2023-08: 0 reports for this device; peer average 11.98/device2023-09: 0 reports for this device; peer average 9.29/device2023-10: 4 reports for this device; peer average 12.14/device2023-11: 2 reports for this device; peer average 6.69/device2023-12: 0 reports for this device; peer average 10.84/device2024-01: 0 reports for this device; peer average 7.89/device2024-02: 0 reports for this device; peer average 11.03/device2024-03: 0 reports for this device; peer average 19.86/device2024-04: 0 reports for this device; peer average 37.72/device2024-05: 0 reports for this device; peer average 46.73/device2024-06: 0 reports for this device; peer average 38.81/device2024-07: 0 reports for this device; peer average 33.83/device2024-08: 2 reports for this device; peer average 16.63/device2024-09: 0 reports for this device; peer average 16.46/device2024-10: 0 reports for this device; peer average 11.54/device2024-11: 2 reports for this device; peer average 10.1/device2024-12: 0 reports for this device; peer average 7.89/device2025-01: 0 reports for this device; peer average 7.58/device2025-02: 0 reports for this device; peer average 6.11/device2025-03: 0 reports for this device; peer average 7.3/device2025-04: 0 reports for this device; peer average 7.87/device2025-05: 0 reports for this device; peer average 8.57/device2025-06: 0 reports for this device; peer average 8.17/device2025-07: 2 reports for this device; peer average 5.91/device2025-08: 1 reports for this device; peer average 7.2/device2025-09: 0 reports for this device; peer average 5.11/device2025-10: 0 reports for this device; peer average 5.73/device2025-11: 0 reports for this device; peer average 9.89/device2025-12: 0 reports for this device; peer average 6.73/device2026-01: 0 reports for this device; peer average 7.79/device2026-02: 0 reports for this device; peer average 10.15/device2026-03: 1 reports for this device; peer average 7.25/device2026-04: 2 reports for this device; peer average 8.01/device2026-05: 0 reports for this device; peer average 8.22/device2026-06: 0 reports for this device; peer average 8.9/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0115.06
2019-0204.07
2019-0304.63
2019-0404.62
2019-0504.69
2019-0604.3
2019-0705
2019-0806.17
2019-0905.48
2019-1005.14
2019-1137.13
2019-1206.59
2020-0106.93
2020-0205.15
2020-0346.97
2020-0408.85
2020-0507.63
2020-0616.74
2020-0706.71
2020-0806.78
2020-0906.02
2020-1007.39
2020-1108.82
2020-1209.67
2021-0109.29
2021-0209.91
2021-0308.62
2021-0408.69
2021-0507.86
2021-0606.39
2021-0708.38
2021-0806.93
2021-0907.23
2021-1027.79
2021-1108.31
2021-1208.71
2022-0106.9
2022-0207.45
2022-0308.41
2022-0406.2
2022-0507.71
2022-0606.51
2022-0706.39
2022-0809
2022-0907.01
2022-1008.23
2022-1109.39
2022-1208.84
2023-0109.38
2023-0209.48
2023-03111.29
2023-04011.77
2023-05011.2
2023-06012.06
2023-07013.11
2023-08011.98
2023-0909.29
2023-10412.14
2023-1126.69
2023-12010.84
2024-0107.89
2024-02011.03
2024-03019.86
2024-04037.72
2024-05046.73
2024-06038.81
2024-07033.83
2024-08216.63
2024-09016.46
2024-10011.54
2024-11210.1
2024-1207.89
2025-0107.58
2025-0206.11
2025-0307.3
2025-0407.87
2025-0508.57
2025-0608.17
2025-0725.91
2025-0817.2
2025-0905.11
2025-1005.73
2025-1109.89
2025-1206.73
2026-0107.79
2026-02010.15
2026-0317.25
2026-0428.01
2026-0508.22
2026-0608.9
This device (reports/month)Average device in GAT, NEW (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2026-04-091221934-2026-01472MalfunctionAvailablecatalog number
2026-03-241221934-2026-01205MalfunctionAvailableexact di
2025-08-141221934-2025-03123MalfunctionAvailableexact di
2025-07-111221934-2025-02558MalfunctionAvailablecatalog number
2024-11-081221934-2024-03991MalfunctionAvailablecatalog number
2024-08-281221934-2024-02994MalfunctionAvailablecatalog number
2023-11-071221934-2023-04032MalfunctionAvailableexact di
2023-11-071221934-2023-04033MalfunctionAvailableexact di
2023-10-261221934-2023-03902MalfunctionAvailablecatalog number
2023-10-261221934-2023-03901MalfunctionAvailablecatalog number
2023-03-291221934-2023-01363MalfunctionAvailableexact di
2021-10-291221934-2021-03209MalfunctionAvailableexact di
2021-10-291221934-2021-03208MalfunctionAvailableexact di
2020-06-291221934-2020-01694MalfunctionAvailableexact di
2020-03-251221934-2020-00980MalfunctionAvailablecatalog number

Showing the most recent 18 of 28 linked reports.

Showing 1–15 of 18
Regulatory clearances

    Predicate lineage

    K040004

    Cited as predicate by: K094028, K103712, K123668, K130814, K130917, K161638, K162247, K181182, K223822, K232492

    Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

    Manufacturer compliance record

    None in the loaded window.

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