BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 4002375 · Received August 12, 2014

    Report

    Report Number
    1531186-2014-03144
    Date Received
    August 12, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 2014
    Manufacturer
    JIANGSU YUYUE MEDICAL EQUIP.
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PROVIDER STATES THAT THE BRACKET FOR THE BRAKES WAS NOT WELDED CORRECTLY, SO THE USER COULD NOT USE HER BRAKES. PROVIDER STATES IN ORDER TO MAKE THE BRAKES WORK HE HAD TO FILE SOME OF THE BRACKET. THIS ISSUE HAS ALSO CAUSED A DEAD SPOT IN THE WHEEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479891 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR JIANGSU YUYUE MEDICAL EQUIP. TRHD22FR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other