BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMIERPRO

    MDR report key: 18490971 · Received January 11, 2024

    Report

    Report Number
    18490971
    Event Type
    Malfunction
    Date Received
    January 11, 2024
    Date of Event
    October 17, 2023
    Report Date
    November 9, 2023
    Manufacturer
    SVS LLC
    Product Code
    FQM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PREMIERPRO ARE TEARING EASILY AND BECOMING ABNORMALLY STICKY AFTER CONTACT WITH PATIENT FLUIDS. THE PREMIERPRO BANDAGE IS MAKING OUR GLOVES STICKY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    954490 PREMIERPRO BANDAGE, ELASTIC FQM SVS LLC 8956 CDSM06-02

    Patients

    Seq Age Sex Outcome Treatment
    1 27375 DA Unknown