BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATTRESS COVER FOR MEDICAL PURPOSES

    MDR report key: 4092545 · Received September 16, 2014

    Report

    Report Number
    1031452-2014-09444
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 20, 2014
    Report Date
    August 20, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    FMW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER ALLEGED THAT THE MATTRESS IS NOT MAINTAINING PRESSURE IN THE CENTER AND THE FOOT SECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572540 MATTRESS COVER FOR MEDICAL PURPOSES 880.6190 FMW INVACARE FLORIDA OPERATIONS BB9572000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other