BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3960774 · Received July 28, 2014

    Report

    Report Number
    1525712-2014-04020
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 20, 2014
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4) - NO INJURY ALLEGED. MALFUNCTION ALLEGED. DEALER ADVISED BRACKET THAT HOLDS THE CALF PAD IS BENT AND TWISTED, NO INJURY, DEALER COULD NOT PROVIDE ANY FURTHER INFORMATION...(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437703 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET 3GRX-CG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other