BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATTRESS COVER FOR MEDICAL PURPOSES

    MDR report key: 3884685 · Received June 19, 2014

    Report

    Report Number
    1031452-2014-02251
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    February 3, 2014
    Report Date
    May 20, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    FMW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER END USER¿S FAMILY MEMBER, THE HOSE IS LEAKING ON THE LEFT SIDE OF THE TURN-Q PLUS MATTRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361127 MATTRESS COVER FOR MEDICAL PURPOSES 880.6190 FMW INVACARE FLORIDA OPERATIONS TURN-Q PLUS

    Patients

    Seq Age Sex Outcome Treatment
    1 27 Other