BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3007996 · Received March 17, 2013

    Report

    Report Number
    1525712-2013-02069
    Event Type
    Malfunction
    Date Received
    March 17, 2013
    Report Date
    February 20, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATES THE CALF PADS ON THE LNX ARE CAUSING THE CONSUMER TO GET SORES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111144 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSP-MCG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other