BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARMED ULTRA NITRILE EXAM GLOVE

    MDR report key: 12494744 · Received September 20, 2021

    Report

    Report Number
    12494744
    Event Type
    Malfunction
    Date Received
    September 20, 2021
    Date of Event
    September 9, 2021
    Report Date
    September 13, 2021
    Manufacturer
    SEMPERMED
    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 WOUND CARE OBTAINING A GLOVE OUT OF A FULL BOX OF GLOVES. HOLE IN THUMB OF GLOVE WHEN REMOVED FROM BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1394712 STARMED ULTRA NITRILE EXAM GLOVE MEDICAL GLOVES W/ CHEMOTHERAPY LABELING CLAIMS - FOR USE W/ CHEMOTHERAPY DRUGS OPJ SEMPERMED L0794972103

    Patients

    Seq Age Sex Outcome Treatment
    1