BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARMED ULTRA NITRILE EXAM GLOVE

    MDR report key: 12353304 · Received August 23, 2021

    Report

    Report Number
    12353304
    Event Type
    Malfunction
    Date Received
    August 23, 2021
    Date of Event
    August 17, 2021
    Report Date
    August 17, 2021
    Manufacturer
    SEMPERMED USA, INC.
    Product Code
    OPJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN THE STARMED ULTRA NITRILE EXAM GLOVE WAS REMOVED FROM THE BOX, IT WAS EVIDENT THAT IT WAS RIPPED FROM WRIST TO FIRST KNUCKLE OF MIDDLE FINGER (MFG DATE/LOT # 2020-09 L66366 2009).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1250260 STARMED ULTRA NITRILE EXAM GLOVE MEDICAL GLOVES W/ CHEMOTHERAPY LABELING CLAIMS - FOR USE W/ CHEMOTHERAPY DRUGS OPJ SEMPERMED USA, INC. SMTN254 L0663662009

    Patients

    Seq Age Sex Outcome Treatment
    1