BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 4213020 · Received October 30, 2014

    Report

    Report Number
    1525712-2014-07443
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Report Date
    October 9, 2014
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PROVIDER STATES THAT THE CUSHIONS ARE WORN OFF OF THE LEGRESTS WHICH IS CAUSING RUBBING ON THE CONSUMER LEGS. PROVIDER WAS NOT MADE AWARE OF ANY INJURIES CAUSED BY THIS ISSUE. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696091 POWERED WHEELCHAIR 890.3860 ITJ INVACARE TAYLOR STREET TDXSR-CG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other