BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARMED ULTRA NITRILE EXAM GLOVE

    MDR report key: 10028318 · Received May 6, 2020

    Report

    Report Number
    10028318
    Event Type
    Malfunction
    Date Received
    May 6, 2020
    Date of Event
    April 23, 2020
    Report Date
    April 30, 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 NOTED TO BE DAMAGED WHEN REMOVED FROM THE BOX. ONE GLOVE WAS STUCK INSIDE ANOTHER GLOVE. GLOVED APPEARED TO BE MATTED OR MELTED TOGETHER. GLOVE AVAILABLE FOR RETURN TO MANUFACTURER. THIS IS A RECURRING PROBLEM. THE MANUFACTURER HAS BEEN NOTIFIED. MULTIPLE AFFECTED PRODUCT SAMPLES HAVE BEEN RETURNED. THE PROBLEM CONTINUES. MULTIPLE LOTS WITHIN MULTIPLE CATALOG NUMBERS ARE AFFECTED. MANUFACTURER RESPONSE FOR HEALTHCARE GLOVES, STARMED ULTRA NITRILE S (PER SITE REPORTER). QUALITY EVENT REPORT SUBMITTED TO MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493523 STARMED ULTRA NITRILE EXAM GLOVE MEDICAL GLOVES WITH CHEMOTHERAPY OPJ SEMPERMED USA, INC. SMTN253 L048828 1911

    Patients

    Seq Age Sex Outcome Treatment
    1