BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 4132873 · Received October 1, 2014

    Report

    Report Number
    1525712-2014-06567
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 12, 2014
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CONSUMER STATES THAT ONE FRONT RIGGING IS BROKEN DUE TO SOMETHING ON THE FRAME BREAKING WHEN SHE TILTED BACK IN THE VAN. NOT SURE IF IT IS A WELD BREAK ON THE FRAME OR NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613246 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSP-CG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other