BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FITGUARD SELECT NITRILE EXAM GLOVES

    MDR report key: 6180722 · Received December 16, 2016

    Report

    Report Number
    6180722
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Date of Event
    November 4, 2016
    Report Date
    November 30, 2016
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    LZA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE STAFF DONNING GLOVES, THEY EASILY RIPPED. MULTIPLE COMPLAINTS THAT THESE BRAND OF GLOVES RIP TOO EASILY OR ARE FOUND RIPPED WHEN REMOVED FROM THE PACKAGING, HOSPITAL HAS REPORTED SEVERAL CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832713 FITGUARD SELECT NITRILE EXAM GLOVES POLYMER PATIENT EXAMINATION GLOVE LZA MEDLINE INDUSTRIES, INC. KB608567530-1

    Patients

    Seq Age Sex Outcome Treatment
    1