BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREVANTICS® DEVICE SWAB

    MDR report key: 24303647 · Received February 10, 2026

    Report

    Report Number
    24303647
    Event Type
    Malfunction
    Date Received
    February 10, 2026
    Date of Event
    January 26, 2026
    Report Date
    January 26, 2026
    Manufacturer
    PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.
    Product Code
    LKB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PREVANTIC SWAB DEVICE (MFG B19600): WHEN OPENED, SEVERAL OF THE WIPES WERE DRY ON ONE EDGE BUT WET ON THE OTHER. REPORTED AS SPORADIC ISSUE. LOT #100000034, EXP 2027-8-31.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363212 PREVANTICS® DEVICE SWAB PAD, ALCOHOL, DEVICE DISINFECTANT LKB PROFESSIONAL DISPOSABLES INTERNATIONAL, INC. B19600 100000034

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown