BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARMED ULTRA NITRILE EXAM GLOVE

    MDR report key: 9943150 · Received April 9, 2020

    Report

    Report Number
    9943150
    Event Type
    Malfunction
    Date Received
    April 9, 2020
    Date of Event
    February 28, 2020
    Report Date
    April 1, 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

    GLOVE WAS FOUND SO CLUMPED TOGETHER, IT WAS UNUSABLE WHEN REMOVED FROM A BOX OF GLOVES. MANUFACTURER RESPONSE FOR NONSTERILE GLOVES, STARMED ULTRA NITRILE (PER SITE REPORTER). EQUIPMENT FAILURE REPORTED TO (B)(6) CUSTOMER SERVICE LEAD. QUALITY EVENT REPORT EMAILED TO (B)(6) AND REPORT ATTACHED TO THIS MEDSUN REPORT DEFECTIVE GLOVE AVAILABLE FOR RETURN TO MANUFACTURER. AWAITING RESPONSE FROM MANUFACTURER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406134 STARMED ULTRA NITRILE EXAM GLOVE MEDICAL GLOVES WITH CHEMOTHERAPY OPJ SEMPERMED USA, INC. SMTN253 L035211 1901

    Patients

    Seq Age Sex Outcome Treatment
    1