BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3222834 · Received July 12, 2013

    Report

    Report Number
    3004493922-2013-01485
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    May 29, 2013
    Report Date
    June 20, 2013
    Manufacturer
    INVACARE SUZHOU
    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 TIRE SPLIT ON THE CASTORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322694 POWERED WHEELCHAIR 890.3860 ITI INVACARE SUZHOU M41

    Patients

    Seq Age Sex Outcome Treatment
    1 Other