BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3071767 · Received April 22, 2013

    Report

    Report Number
    1525712-2013-03121
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    March 26, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATES THE BACKREST BROKE BECAUSE A SCREW WAS BROKEN AND IT CAUSED THE BACK TO CRACK. HE SAID THE END USER IS ROUGH ON THE BACK AND KEEPS BREAKING THAT HARDWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172195 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE TAYLOR STREET TA4

    Patients

    Seq Age Sex Outcome Treatment
    1 Other