BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARMED ULTRA NITRILE EXAM GLOVE

    MDR report key: 11958553 · Received June 8, 2021

    Report

    Report Number
    11958553
    Event Type
    Malfunction
    Date Received
    June 8, 2021
    Date of Event
    May 24, 2021
    Report Date
    May 25, 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

    STARMED ULTRA NITRILE EXAM GLOVE WAS INTACT WHEN REMOVED FROM THE BOX. HOWEVER, THE INDEX FINGER RIPPED AS SOON AS FINGER INSERTED. THIS PRODUCT HAD BEEN IDENTIFIED AS HAVING RIPS AND UNATTACHED DIGITS WHEN REMOVED FROM THE BOX IN THE PAST BUT HAD NEVER BEEN SAVED. THIS IS THE FIRST IDENTIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854315 STARMED ULTRA NITRILE EXAM GLOVE MEDICAL GLOVES W/ CHEMOTHERAPY LABELING CLAIMS - FOR USE W/ CHEMOTHERAPY DRUGS OPJ SEMPERMED USA, INC. SMTN253 L072304 2012

    Patients

    Seq Age Sex Outcome Treatment
    1