BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARMED ULTRA NITRILE EXAM GLOVE

    MDR report key: 15461155 · Received September 21, 2022

    Report

    Report Number
    15461155
    Event Type
    Malfunction
    Date Received
    September 21, 2022
    Date of Event
    August 22, 2022
    Report Date
    August 24, 2022
    Manufacturer
    SEMPERMED USA, INC.
    Product Code
    OPJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    EMPLOYEE IN WOUND CARE OBTAINING A GLOVE OUT OF A BOX. THE THUMB OF THE GLOVE WAS RIPPED WHEN REMOVED. GLOVE SAVED AND NOT USED FOR PATIENT CARE. 5TH EVENT, SAME NATURE. MANUFACTURER RESPONSE FOR SEMPERMED STARMED ULTRA NITRILE EXAM GLOVES, (BRAND NOT PROVIDED) (PER SITE REPORTER) AWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2728304 STARMED ULTRA NITRILE EXAM GLOVE MEDICAL GLOVES WITH CHEMOTHERAPY LABELING CLAIMS - TEST FOR USE WITH CHEMO OPJ SEMPERMED USA, INC. SMTN254 L012271 2203

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown