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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.

96 linked reportsInjury 91Malfunction 5
51015212019-01: 0 reports for this device; peer average 4/device2019-02: 0 reports for this device; peer average 2.58/device2019-03: 2 reports for this device; peer average 3.29/device2019-04: 0 reports for this device; peer average 4/device2019-05: 0 reports for this device; peer average 2.2/device2019-06: 0 reports for this device; peer average 5/device2019-07: 2 reports for this device; peer average 4.59/device2019-08: 2 reports for this device; peer average 3.42/device2019-09: 3 reports for this device; peer average 2.33/device2019-10: 0 reports for this device; peer average 3.5/device2019-11: 4 reports for this device; peer average 2.93/device2019-12: 0 reports for this device; peer average 4.27/device2020-01: 4 reports for this device; peer average 3.67/device2020-02: 2 reports for this device; peer average 4/device2020-03: 6 reports for this device; peer average 3.88/device2020-04: 0 reports for this device; peer average 3.27/device2020-05: 0 reports for this device; peer average 2.71/device2020-06: 2 reports for this device; peer average 5/device2020-07: 3 reports for this device; peer average 2.05/device2020-08: 2 reports for this device; peer average 2.67/device2020-09: 0 reports for this device; peer average 2.62/device2020-10: 2 reports for this device; peer average 4/device2020-11: 0 reports for this device; peer average 3.31/device2020-12: 7 reports for this device; peer average 4.33/device2021-01: 0 reports for this device; peer average 2.25/device2021-02: 0 reports for this device; peer average 4.14/device2021-03: 0 reports for this device; peer average 3.44/device2021-04: 0 reports for this device; peer average 3.8/device2021-05: 0 reports for this device; peer average 2.69/device2021-06: 0 reports for this device; peer average 6.18/device2021-07: 3 reports for this device; peer average 8/device2021-08: 1 reports for this device; peer average 4.26/device2021-09: 0 reports for this device; peer average 4.29/device2021-10: 0 reports for this device; peer average 5.75/device2021-11: 0 reports for this device; peer average 4.21/device2021-12: 0 reports for this device; peer average 5.58/device2022-01: 2 reports for this device; peer average 4.76/device2022-02: 0 reports for this device; peer average 3.06/device2022-03: 2 reports for this device; peer average 6.19/device2022-04: 3 reports for this device; peer average 4.15/device2022-05: 0 reports for this device; peer average 5/device2022-06: 0 reports for this device; peer average 2.13/device2022-07: 0 reports for this device; peer average 3.87/device2022-08: 0 reports for this device; peer average 3.42/device2022-09: 0 reports for this device; peer average 3.15/device2022-10: 7 reports for this device; peer average 3/device2022-11: 0 reports for this device; peer average 3.89/device2022-12: 0 reports for this device; peer average 11.2/device2023-01: 0 reports for this device; peer average 20.62/device2023-02: 0 reports for this device; peer average 9.35/device2023-03: 3 reports for this device; peer average 12.22/device2023-04: 0 reports for this device; peer average 13.21/device2023-05: 0 reports for this device; peer average 18.4/device2023-06: 0 reports for this device; peer average 18.95/device2023-07: 0 reports for this device; peer average 11.93/device2023-08: 0 reports for this device; peer average 11.5/device2023-09: 0 reports for this device; peer average 10.06/device2023-10: 3 reports for this device; peer average 10.82/device2023-11: 0 reports for this device; peer average 9.45/device2023-12: 0 reports for this device; peer average 11.69/device2024-01: 0 reports for this device; peer average 9.13/device2024-02: 0 reports for this device; peer average 11.61/device2024-03: 3 reports for this device; peer average 12.31/device2024-04: 0 reports for this device; peer average 10.69/device2024-05: 0 reports for this device; peer average 12.26/device2024-06: 0 reports for this device; peer average 9.57/device2024-07: 3 reports for this device; peer average 10.33/device2024-08: 6 reports for this device; peer average 11.61/device2024-09: 0 reports for this device; peer average 13.31/device2024-10: 4 reports for this device; peer average 10.49/device2024-11: 6 reports for this device; peer average 8.09/device2024-12: 0 reports for this device; peer average 12.53/device2025-01: 0 reports for this device; peer average 11.32/device2025-02: 0 reports for this device; peer average 12.94/device2025-03: 3 reports for this device; peer average 9.6/device2025-04: 0 reports for this device; peer average 10.36/device2025-05: 0 reports for this device; peer average 9.76/device2025-06: 0 reports for this device; peer average 9.05/device2025-07: 0 reports for this device; peer average 9.3/device2025-08: 0 reports for this device; peer average 9.82/device2025-09: 0 reports for this device; peer average 9.47/device2025-10: 0 reports for this device; peer average 8.89/device2025-11: 0 reports for this device; peer average 9.82/device2025-12: 3 reports for this device; peer average 9.93/device2026-01: 3 reports for this device; peer average 12.47/device2026-02: 0 reports for this device; peer average 17.64/device2026-03: 0 reports for this device; peer average 8.42/device2026-04: 0 reports for this device; peer average 8.76/device2026-05: 0 reports for this device; peer average 6.15/device2026-06: 0 reports for this device; peer average 8.38/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0104
2019-0202.58
2019-0323.29
2019-0404
2019-0502.2
2019-0605
2019-0724.59
2019-0823.42
2019-0932.33
2019-1003.5
2019-1142.93
2019-1204.27
2020-0143.67
2020-0224
2020-0363.88
2020-0403.27
2020-0502.71
2020-0625
2020-0732.05
2020-0822.67
2020-0902.62
2020-1024
2020-1103.31
2020-1274.33
2021-0102.25
2021-0204.14
2021-0303.44
2021-0403.8
2021-0502.69
2021-0606.18
2021-0738
2021-0814.26
2021-0904.29
2021-1005.75
2021-1104.21
2021-1205.58
2022-0124.76
2022-0203.06
2022-0326.19
2022-0434.15
2022-0505
2022-0602.13
2022-0703.87
2022-0803.42
2022-0903.15
2022-1073
2022-1103.89
2022-12011.2
2023-01020.62
2023-0209.35
2023-03312.22
2023-04013.21
2023-05018.4
2023-06018.95
2023-07011.93
2023-08011.5
2023-09010.06
2023-10310.82
2023-1109.45
2023-12011.69
2024-0109.13
2024-02011.61
2024-03312.31
2024-04010.69
2024-05012.26
2024-0609.57
2024-07310.33
2024-08611.61
2024-09013.31
2024-10410.49
2024-1168.09
2024-12012.53
2025-01011.32
2025-02012.94
2025-0339.6
2025-04010.36
2025-0509.76
2025-0609.05
2025-0709.3
2025-0809.82
2025-0909.47
2025-1008.89
2025-1109.82
2025-1239.93
2026-01312.47
2026-02017.64
2026-0308.42
2026-0408.76
2026-0506.15
2026-0608.38
This device (reports/month)Average device in HIH (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
2026-01-071222780-2026-00016InjuryAvailablecatalog number
2025-12-031222780-2025-00609InjuryAvailablecatalog number
2025-03-281222780-2025-00144InjuryAvailablecatalog number
2024-11-151222780-2024-00432InjuryAvailablecatalog number
2024-11-151222780-2024-00431InjuryAvailablecatalog number
2024-10-301222780-2024-00407MalfunctionAvailablecatalog number
2024-08-141222780-2024-00269InjuryAvailablecatalog number
2024-08-141222780-2024-00267InjuryAvailablecatalog number
2024-07-171222780-2024-00238InjuryAvailablecatalog number
2024-03-151222780-2024-00110InjuryAvailablecatalog number
2024-03-0418833709MalfunctionAvailableprocode brand trgm
2023-10-181222780-2023-00391InjuryAvailablemodel number
2023-10-181222780-2023-00389InjuryAvailablemodel number
2023-03-241222780-2023-00088InjuryAvailablecatalog number
2022-10-191222780-2022-00299InjuryAvailablemodel number

Showing the most recent 41 of 96 linked reports.

Showing 1–15 of 41
Regulatory clearances

    Predicate lineage

    K091465

    Cited as predicate by: K102686, K122563, K182006

    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
    2025-11-04OAIOfficial action indicatedHologic, Inc3
    2025-11-04OAIOfficial action indicatedHologic, Inc3
    2024-12-18WLWarning LetterHologic, Inc—
    2024-12-18WLWarning LetterHologic, Inc—
    2024-09-24OAIOfficial action indicatedHologic, Inc5
    2024-09-24OAIOfficial action indicatedHologic, Inc5
    2024-09-12VAIVoluntary action indicatedHologic Surgical Products Costa Rica, S.R.L.0
    2024-08-13NAINo action indicatedHologic, Inc.0
    2024-08-13NAINo action indicatedHologic, Inc.0
    2022-12-14NAINo action indicatedBolder Surgical, LLC0
    2022-10-14OAIOfficial action indicatedHologic, Inc.4
    2022-10-14OAIOfficial action indicatedHologic, Inc.4
    2022-08-03VAIVoluntary action indicatedHealth Beacons, Inc.1
    2020-02-25NAINo action indicatedHealth Beacons, Inc.0
    2018-12-10NAINo action indicatedHologic, Inc.0
    2018-12-10NAINo action indicatedHologic, Inc.0
    2018-02-27NAINo action indicatedGynesonics, Inc.0
    2017-11-30NAINo action indicatedHologic, Inc0
    2017-11-30NAINo action indicatedHologic, Inc0
    2017-11-27VAIVoluntary action indicatedBolder Surgical, LLC6
    2017-10-25NAINo action indicatedHologic, Inc.0
    2017-10-25NAINo action indicatedHologic, Inc.0
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