BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARMED ULTRA NITRILE EXAM GLOVE

    MDR report key: 16568968 · Received March 17, 2023

    Report

    Report Number
    16568968
    Event Type
    Malfunction
    Date Received
    March 17, 2023
    Date of Event
    February 27, 2023
    Report Date
    February 28, 2023
    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

    WHEN THE NURSE WENT TO REMOVE A GLOVE FROM THE BOX, A MASS OF GLOVES (18) WERE STUCK TOGETHER AND NOT USABLE. THE AREA THAT JOINED THE GLOVES WAS WHITE IN COLOR AS IF THEY WERE MELTED TOGETHER. GLOVES NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1009828 STARMED ULTRA NITRILE EXAM GLOVE MEDICAL GLOVES WITH CHEMOTHERAPY LABELING CLAIMS - TEST FOR USE WITH CHEMO OPJ SEMPERMED USA, INC. SMTN254 L010596

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown