BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 4120314 · Received September 26, 2014

    Report

    Report Number
    1525712-2014-06331
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Report Date
    May 29, 2014
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER WAS INSTALLING SOLID INSERT ON RIM AND PIECES OF PLASTIC BROKE AWAY FROM RIM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601396 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET RP192014

    Patients

    Seq Age Sex Outcome Treatment
    1 Other