BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 4140899 · Received October 3, 2014

    Report

    Report Number
    1525712-2014-06671
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Report Date
    September 17, 2014
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATES USER WORE THE FRONT CASTER WHEELS DOWN TO THE WHEEL HUB. THE CASTER BEARINGS AND SPACERS WERE FUSED TO THE CASTER FORK. NO USER INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618472 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSP-CG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other