BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3955722 · Received July 24, 2014

    Report

    Report Number
    1531186-2014-02715
    Date Received
    July 24, 2014
    Date of Event
    May 28, 2014
    Report Date
    June 17, 2014
    Manufacturer
    JIANGSU YUYUE MEDICAL EQUIP.
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER PROVIDER, STATES THAT THE CUSTOMER HAD THE CHAIR FOR ABOUT A MONTH AND THE SEAT UPHOLSTERY IS COMING UNDONE AT THE SEAMS. PROVIDER STATES THAT THE CUSHION IS STARTING TO COME OUT BECAUSE IT IS COMING UNDONE. PROVIDER DID NOT HAVE END USERS INFORMATION AVAILABLE. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434388 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR JIANGSU YUYUE MEDICAL EQUIP. TRHD22FR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other