BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMIERPRO PLUS NITRILE EXAM GLOVE LARGE

    MDR report key: 20223642 · Received September 16, 2024

    Report

    Report Number
    20223642
    Event Type
    Malfunction
    Date Received
    September 16, 2024
    Date of Event
    April 17, 2024
    Report Date
    May 20, 2024
    Manufacturer
    SVS LLC
    Product Code
    LZC
    UDI-DI
    00818566011039
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    GLOVES RIPPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1114547 PREMIERPRO PLUS NITRILE EXAM GLOVE LARGE PATIENT EXAMINATION GLOVE, SPECIALTY LZC SVS LLC 5064 CZM 11-23 00818566011039

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown