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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.

2 linked reportsMalfunction 2
11222026-05: 0 reports for this device; peer average 2/device2026-06: 2 reports for this device; peer average 2/device0506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2026-0502
2026-0622
This device (reports/month)Average device in NFT (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2026-06-021417592-2026-01994MalfunctionAvailablecatalog number

Showing the most recent 1 of 2 linked reports.

Regulatory clearances

    Predicate lineage

    Cited as predicate by: K191841, K202567, K210327, K220685, K222667, K242077, K252550

    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
    2026-03-26WLWarning LetterMedLine Industries, LP (NAMIC Division)—
    2025-12-12OAIOfficial action indicatedMedLine Industries, LP (NAMIC Division)5
    2025-04-22NAINo action indicatedMICROTEK MEDICAL LLC0
    2024-03-18WLWarning LetterMedline Industries, LP—
    2024-03-18WLWarning LetterMedline Industries, LP—
    2024-01-29NAINo action indicatedMedline Industries LP0
    2024-01-29NAINo action indicatedMedline Industries LP0
    2024-01-22OAIOfficial action indicatedMedline Industries, LP5
    2024-01-22OAIOfficial action indicatedMedline Industries, LP5
    2023-11-01NAINo action indicatedMedline Industries, LP0
    2023-11-01NAINo action indicatedMedline Industries, LP0
    2023-07-26NAINo action indicatedMedline Industries LP0
    2023-07-26NAINo action indicatedMedline Industries LP0
    2023-02-10NAINo action indicatedCenturion Medical Products, LP0
    2022-04-06VAIVoluntary action indicatedMedline Industries, LP0
    2022-04-06VAIVoluntary action indicatedMedline Industries, LP0
    2022-04-05NAINo action indicatedCenturion Medical Products, LP0
    2022-03-28NAINo action indicatedMedline Industries, LP0
    2022-03-28NAINo action indicatedMedline Industries, LP0
    2020-06-11WLWarning LetterCenturion Medical Products, LP—
    2019-11-01OAIOfficial action indicatedCenturion Medical Products, LP5
    2019-10-17NAINo action indicatedMedline Industries LP0
    2019-10-17NAINo action indicatedMedline Industries LP0
    2019-08-20OAIOfficial action indicatedCenturion Medical Products, LP5
    2014-11-07WLWarning LetterExcelsior Medical LLC—
    2014-03-11WLWarning LetterMedline Industries, LP—
    2014-03-11WLWarning LetterMedline Industries, LP—
    2010-03-12WLWarning LetterMedline Industries, LP—
    2010-03-12WLWarning LetterMedline Industries, LP—
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