BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3011727 · Received March 19, 2013

    Report

    Report Number
    1525712-2013-02095
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Report Date
    February 20, 2013
    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

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. DEALER ALLEGES THE GEARBOXES WERE LEAKING GREASE AND DEALER HAD TO PAY TO CLEAN A WHITE RUG THAT GOT GREASE ON IT. RIGHT GEARBOX LEAKING. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113406 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET M51PMPUBL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other