BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARMED ULTRA NITRILE EXAM GLOVE

    MDR report key: 10167117 · Received June 18, 2020

    Report

    Report Number
    10167117
    Event Type
    Malfunction
    Date Received
    June 18, 2020
    Date of Event
    May 7, 2020
    Report Date
    May 29, 2020
    Manufacturer
    SEMPERMED USA, INC.
    Product Code
    OPJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    STARMED ULTRA NITRILE GLOVE WAS NOTED TO BE RIPPED FROM WRIST TO MIDDLE FINGER. DEFECTIVE GLOVE AND ASSOCIATED BOX OF GLOVES AVAILABLE FOR RETURN TO MANUFACTURER. MANUFACTURER RESPONSE FOR HEALTHCARE GLOVES, STARMED ULTRA NITRILE M (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632420 STARMED ULTRA NITRILE EXAM GLOVE MEDICAL GLOVES WITH CHEMOTHERAPY OPJ SEMPERMED USA, INC. SMTN253 2019-09 L046666 1909

    Patients

    Seq Age Sex Outcome Treatment
    1