BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3230116 · Received July 16, 2013

    Report

    Report Number
    3004493922-2013-01507
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Report Date
    June 25, 2013
    Manufacturer
    INVACARE SUZHOU
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE DEALER REPORTS THE ARMPAD IS BANGED UP, AND THE RUBBER IS RUBBED OFF AND HAS SHARP EDGES. NOT ON THIS ORDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328727 POWERED WHEELCHAIR 890.3860 ITI INVACARE SUZHOU M41

    Patients

    Seq Age Sex Outcome Treatment
    1 Other