BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3203307 · Received July 2, 2013

    Report

    Report Number
    1525712-2013-05291
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    June 10, 2013
    Manufacturer
    UNKNOWN
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE END USER STATED THE SEAT HAS BECOME LOOSE AND WOBBLY. THE END USER IS IN A LONG TERM CARE FACILITY AND ISN'T THE ORIGINAL OWNER OF THE CHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302943 POWERED WHEELCHAIR 890.3860 ITI UNKNOWN M51

    Patients

    Seq Age Sex Outcome Treatment
    1 Other