BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FITGUARD SELECT NITRILE EXAM GLOVES

    MDR report key: 6085812 · Received November 8, 2016

    Report

    Report Number
    6085812
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Date of Event
    October 10, 2016
    Report Date
    October 21, 2016
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    LZA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SURGICAL GLOVES TORE DURING ROUTINE PATIENT CARE WHILE POSITIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736711 FITGUARD SELECT NITRILE EXAM GLOVES POLYMER PATIENT EXAMINATION GLOVE LZA MEDLINE INDUSTRIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1