BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARMED ULTRA NITRILE EXAM GLOVE

    MDR report key: 12688354 · Received October 25, 2021

    Report

    Report Number
    12688354
    Event Type
    Malfunction
    Date Received
    October 25, 2021
    Date of Event
    October 13, 2021
    Report Date
    October 14, 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

    EMPLOYEE IN THE WOUND CARE WAS OBTAINING A GLOVE OUT A BOX. A HOLE WAS FOUND IN THE THUMB OF GLOVE WHEN REMOVED. FOURTH EVENT OF THIS SAME NATURE ON SAME PRODUCT SENT TO MEDSUN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1591054 STARMED ULTRA NITRILE EXAM GLOVE MEDICAL GLOVES W CHEMOTHERAPY LABELING CLAIMS FOR USE W CHEMOTHERAPY DRUGS OPJ SEMPERMED USA, INC. L077572 2103

    Patients

    Seq Age Sex Outcome Treatment
    1