BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3230320 · Received July 16, 2013

    Report

    Report Number
    1525712-2013-05826
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Report Date
    June 26, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER ALLEGES THE QUAD SINCE THE FIRST DAY WAS GETTING CAUGHT UP BUT THE DEALER DID NOT TIGHTEN THE BOLTS AND CONSUMER CONTINUED TO USE IT SO NOW IT HAS A GROVE WHERE IT GOT TIED UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330023 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET 3GTQ3

    Patients

    Seq Age Sex Outcome Treatment
    1 Other