BEUDAMED
    FDA Adverse Event Summary report: N

    MATTRESS COVER FOR MEDICAL PURPOSES

    MDR report key: 3834867 · Received May 28, 2014

    Report

    Report Number
    1531186-2014-01982
    Date Received
    May 28, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 15, 2014
    Manufacturer
    GRAND HEALTHCARE CO., LTD.
    Product Code
    FMW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATED, THE MATTRESS WILL NOT INFLATE BECAUSE THE POWER UNIT WILL NOT POWER ON CAUSING THE USERS BED SORES TO GET WORSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313499 MATTRESS COVER FOR MEDICAL PURPOSES 880.6190 FMW GRAND HEALTHCARE CO., LTD. CG9701

    Patients

    Seq Age Sex Outcome Treatment
    1 Other