BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3051747 · Received April 10, 2013

    Report

    Report Number
    1525712-2013-02748
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Report Date
    March 14, 2013
    Manufacturer
    UNKNOWN
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PER CONSUMER WHILE DRIVING THE CHAIR DOESN'T GO IN A STRAIGHT LINE. WHEN PUSHING THE JOYSTICK KNOW FORWARD THE KNOB IS VERY LOOSE. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152549 POWERED WHEELCHAIR 890.3860 ITI UNKNOWN M41

    Patients

    Seq Age Sex Outcome Treatment
    1 91 Other