BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMIER PRO PLUS

    MDR report key: 8700003 · Received June 14, 2019

    Report

    Report Number
    8700003
    Event Type
    Malfunction
    Date Received
    June 14, 2019
    Date of Event
    May 15, 2019
    Report Date
    May 20, 2019
    Manufacturer
    SVS LLC
    Product Code
    LZA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    GLOVES ARE TEARING/RIPPING WHEN STAFF IS USING THEM. GLOVES INFO.: PREMIER PRO PLUS, NITRILE EXAM GLOVES, LOT#S: CEH 05-07; CEH 09-16; CEG 05-38. GLOVES SEEM TO BE RIPPING AND TEARING WITH THE SLIGHTEST USAGE. STAFF IS TRYING SEVERAL FROM THE SAME BOX. HAVE BEEN INSTRUCTED TO COLLECT THE BOXES OF GLOVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494435 PREMIER PRO PLUS POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE LZA SVS LLC CEH 05-07

    Patients

    Seq Age Sex Outcome Treatment
    1 Other