BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PDI NAIL POLISH REMOVER

    MDR report key: 8639785 · Received May 24, 2019

    Report

    Report Number
    8639785
    Event Type
    Malfunction
    Date Received
    May 24, 2019
    Date of Event
    May 17, 2019
    Report Date
    May 20, 2019
    Manufacturer
    PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.
    Product Code
    LKB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    RECENTLY WE MADE A PROCESS IMPROVEMENT TEAM (PITS) FORM OUT FOR DEFECTIVE NAIL POLISH REMOVER PADS BEING NOT EFFECTIVE. THEY WERE RETURNED TO SUPPLY CHAIN AND WE RECEIVED A NEW SUPPLY, WHICH ALSO DEEMED INEFFECTIVE. WE OBTAINED NEW PADS FROM EVERY DEPARTMENT IN THE HOSPITAL THAT HAD THEM, AND ALL WERE INEFFECTIVE AT REMOVING THE POLISH. THE POLICY STATES WE NEED TO HAVE NAIL POLISH REMOVED ON AFFECTED EXTREMITY. THE PATIENT'S HUSBAND LEFT, BOUGHT A BOTTLE OF REMOVER, AND THE POLISH PROMPTLY CAME OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433917 PDI NAIL POLISH REMOVER PAD, ALCOHOL, DEVICE DISINFECTANT LKB PROFESSIONAL DISPOSABLES INTERNATIONAL, INC. B71200 11400763

    Patients

    Seq Age Sex Outcome Treatment
    1 25550 DA