BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FITGUARD SELECT NITRILE EXAM GLOVES

    MDR report key: 6135376 · Received November 30, 2016

    Report

    Report Number
    6135376
    Event Type
    Malfunction
    Date Received
    November 30, 2016
    Date of Event
    October 12, 2016
    Report Date
    October 27, 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 ATTEMPTING TO PUT THE GLOVES ON, THE GLOVES RIPPED AT THE BASE OF THE GLOVE. CONCERN WITH EASY RIPPING OF THE GLOVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786487 FITGUARD SELECT NITRILE EXAM GLOVES POLYMER PATIENT EXAMINATION GLOVE LZA MEDLINE INDUSTRIES, INC. FG2602 EG608567553

    Patients

    Seq Age Sex Outcome Treatment
    1