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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.

4 linked reportsMalfunction 3Injury 1
11222019-01: 0 reports for this device; peer average 1.76/device2019-02: 0 reports for this device; peer average 1.61/device2019-03: 0 reports for this device; peer average 1.73/device2019-04: 0 reports for this device; peer average 1.93/device2019-05: 0 reports for this device; peer average 1.6/device2019-06: 0 reports for this device; peer average 1.3/device2019-07: 0 reports for this device; peer average 1.4/device2019-08: 0 reports for this device; peer average 1.61/device2019-09: 0 reports for this device; peer average 1.47/device2019-10: 0 reports for this device; peer average 1.57/device2019-11: 0 reports for this device; peer average 1.66/device2019-12: 0 reports for this device; peer average 1.55/device2020-01: 0 reports for this device; peer average 1.57/device2020-02: 0 reports for this device; peer average 1.55/device2020-03: 0 reports for this device; peer average 1.84/device2020-04: 0 reports for this device; peer average 1.52/device2020-05: 0 reports for this device; peer average 1.32/device2020-06: 0 reports for this device; peer average 1.45/device2020-07: 0 reports for this device; peer average 1.72/device2020-08: 0 reports for this device; peer average 1.48/device2020-09: 0 reports for this device; peer average 1.61/device2020-10: 1 reports for this device; peer average 1.61/device2020-11: 0 reports for this device; peer average 1.48/device2020-12: 1 reports for this device; peer average 1.56/device2021-01: 0 reports for this device; peer average 1.54/device2021-02: 0 reports for this device; peer average 1.43/device2021-03: 0 reports for this device; peer average 1.46/device2021-04: 0 reports for this device; peer average 1.53/device2021-05: 0 reports for this device; peer average 1.53/device2021-06: 0 reports for this device; peer average 1.6/device2021-07: 0 reports for this device; peer average 1.46/device2021-08: 0 reports for this device; peer average 1.39/device2021-09: 0 reports for this device; peer average 1.84/device2021-10: 0 reports for this device; peer average 1.51/device2021-11: 0 reports for this device; peer average 1.5/device2021-12: 0 reports for this device; peer average 1.4/device2022-01: 0 reports for this device; peer average 1.37/device2022-02: 1 reports for this device; peer average 1.47/device2022-03: 0 reports for this device; peer average 1.44/device2022-04: 0 reports for this device; peer average 1.41/device2022-05: 0 reports for this device; peer average 1.64/device2022-06: 0 reports for this device; peer average 1.55/device2022-07: 0 reports for this device; peer average 1.44/device2022-08: 0 reports for this device; peer average 1.65/device2022-09: 0 reports for this device; peer average 1.67/device2022-10: 0 reports for this device; peer average 1.59/device2022-11: 1 reports for this device; peer average 1.68/device2022-12: 0 reports for this device; peer average 1.37/device2023-01: 0 reports for this device; peer average 1.35/device2023-02: 0 reports for this device; peer average 1.48/device2023-03: 0 reports for this device; peer average 1.64/device2023-04: 0 reports for this device; peer average 1.79/device2023-05: 0 reports for this device; peer average 1.68/device2023-06: 0 reports for this device; peer average 1.9/device2023-07: 0 reports for this device; peer average 1.9/device2023-08: 0 reports for this device; peer average 1.71/device2023-09: 0 reports for this device; peer average 1.82/device2023-10: 0 reports for this device; peer average 1.42/device2023-11: 0 reports for this device; peer average 1.36/device2023-12: 0 reports for this device; peer average 1.4/device2024-01: 0 reports for this device; peer average 1.47/device2024-02: 0 reports for this device; peer average 1.67/device2024-03: 0 reports for this device; peer average 1.88/device2024-04: 0 reports for this device; peer average 1.63/device2024-05: 0 reports for this device; peer average 2.19/device2024-06: 0 reports for this device; peer average 1.9/device2024-07: 0 reports for this device; peer average 1.51/device2024-08: 0 reports for this device; peer average 1.99/device2024-09: 0 reports for this device; peer average 1.82/device2024-10: 0 reports for this device; peer average 1.66/device2024-11: 0 reports for this device; peer average 1.39/device2024-12: 0 reports for this device; peer average 1.45/device2025-01: 0 reports for this device; peer average 1.64/device2025-02: 0 reports for this device; peer average 1.43/device2025-03: 0 reports for this device; peer average 1.71/device2025-04: 0 reports for this device; peer average 1.65/device2025-05: 0 reports for this device; peer average 1.44/device2025-06: 0 reports for this device; peer average 1.66/device2025-07: 0 reports for this device; peer average 1.59/device2025-08: 0 reports for this device; peer average 1.44/device2025-09: 0 reports for this device; peer average 1.48/device2025-10: 0 reports for this device; peer average 1.47/device2025-11: 0 reports for this device; peer average 1.59/device2025-12: 0 reports for this device; peer average 1.76/device2026-01: 0 reports for this device; peer average 1.61/device2026-02: 0 reports for this device; peer average 1.46/device2026-03: 0 reports for this device; peer average 1.87/device2026-04: 0 reports for this device; peer average 1.67/device2026-05: 0 reports for this device; peer average 1.46/device2026-06: 0 reports for this device; peer average 1.61/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.76
2019-0201.61
2019-0301.73
2019-0401.93
2019-0501.6
2019-0601.3
2019-0701.4
2019-0801.61
2019-0901.47
2019-1001.57
2019-1101.66
2019-1201.55
2020-0101.57
2020-0201.55
2020-0301.84
2020-0401.52
2020-0501.32
2020-0601.45
2020-0701.72
2020-0801.48
2020-0901.61
2020-1011.61
2020-1101.48
2020-1211.56
2021-0101.54
2021-0201.43
2021-0301.46
2021-0401.53
2021-0501.53
2021-0601.6
2021-0701.46
2021-0801.39
2021-0901.84
2021-1001.51
2021-1101.5
2021-1201.4
2022-0101.37
2022-0211.47
2022-0301.44
2022-0401.41
2022-0501.64
2022-0601.55
2022-0701.44
2022-0801.65
2022-0901.67
2022-1001.59
2022-1111.68
2022-1201.37
2023-0101.35
2023-0201.48
2023-0301.64
2023-0401.79
2023-0501.68
2023-0601.9
2023-0701.9
2023-0801.71
2023-0901.82
2023-1001.42
2023-1101.36
2023-1201.4
2024-0101.47
2024-0201.67
2024-0301.88
2024-0401.63
2024-0502.19
2024-0601.9
2024-0701.51
2024-0801.99
2024-0901.82
2024-1001.66
2024-1101.39
2024-1201.45
2025-0101.64
2025-0201.43
2025-0301.71
2025-0401.65
2025-0501.44
2025-0601.66
2025-0701.59
2025-0801.44
2025-0901.48
2025-1001.47
2025-1101.59
2025-1201.76
2026-0101.61
2026-0201.46
2026-0301.87
2026-0401.67
2026-0501.46
2026-0601.61
This device (reports/month)Average device in MEH (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2022-11-081038671-2022-01420MalfunctionAvailableexact di
2022-02-091038671-2022-00192MalfunctionAvailableexact di
2020-12-181038671-2020-00655InjuryAvailableexact di
2020-10-301038671-2020-00593MalfunctionAvailableexact di
Regulatory clearances

    Predicate lineage

    K080980

    Cited as predicate by: K103012, K113320, K121297, K153649

    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
    DateTypeOutcomeFacilityCitations
    2025-12-19WLWarning LetterExactech Sarasota, Inc.—
    2025-08-27OAIOfficial action indicatedExactech, Inc.9
    2025-08-27OAIOfficial action indicatedExactech, Inc.9
    2025-07-25OAIOfficial action indicatedExactech Sarasota, Inc.7
    2024-10-09VAIVoluntary action indicatedExactech, Inc.0
    2024-10-09VAIVoluntary action indicatedExactech, Inc.0
    2024-01-19WLWarning LetterExactech, Inc.—
    2024-01-19WLWarning LetterExactech, Inc.—
    2023-09-26OAIOfficial action indicatedExactech, Inc.2
    2023-09-26OAIOfficial action indicatedExactech, Inc.2
    2021-11-17VAIVoluntary action indicatedExactech, Inc.4
    2021-11-17VAIVoluntary action indicatedExactech, Inc.4
    2020-01-31VAIVoluntary action indicatedExactech, Inc.7
    2020-01-31VAIVoluntary action indicatedExactech, Inc.7
    2017-03-10VAIVoluntary action indicatedExactech, Inc.7
    2017-03-10VAIVoluntary action indicatedExactech, Inc.7
    2015-07-16NAINo action indicatedExactech, Inc.0
    2015-07-16NAINo action indicatedExactech, Inc.0
    2014-08-25NAINo action indicatedExactech Sarasota, Inc.0
    2012-12-11NAINo action indicatedExactech, Inc.0
    2012-12-11NAINo action indicatedExactech, Inc.0
    2010-03-25VAIVoluntary action indicatedExactech, Inc.0
    2010-03-25VAIVoluntary action indicatedExactech, Inc.0
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