BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 4142516 · Received October 6, 2014

    Report

    Report Number
    1525712-2014-06600
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Report Date
    September 15, 2014
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER DEALER, THE FRONT RIGGING WAS REPLACED IN (B)(6) PER ORDER (B)(4), BUT THE END USER HAS FEET THAT ARE CURVED OUT AND DOES SHAKE, THE HEEL LOOP PINS ARE BOTH BENT .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624203 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET 3GAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other