BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARMED ULTRA NITRILE EXAM GLOVE

    MDR report key: 10028325 · Received May 6, 2020

    Report

    Report Number
    10028325
    Event Type
    Malfunction
    Date Received
    May 6, 2020
    Date of Event
    April 28, 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 GLOVE REMOVED FROM BOX BY RN. RN NOTED GLOVE TO BE RIPPED. DEFECTIVE GLOVE NOT SAVED. 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 GLOVE, (BRAND NOT PROVIDED) (PER SITE REPORTER). QUALITY EVENT REPORT SUBMITTED TO MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493529 STARMED ULTRA NITRILE EXAM GLOVE MEDICAL GLOVES WITH CHEMOTHERAPY OPJ SEMPERMED USA, INC. SMTN253 L048829 1911

    Patients

    Seq Age Sex Outcome Treatment
    1