BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 4122662 · Received September 26, 2014

    Report

    Report Number
    2081283-2014-00011
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Report Date
    September 3, 2014
    Manufacturer
    FREEDOM DESIGNS INC
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    END USER STATES PART 11 MISSING FROM THE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602016 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR FREEDOM DESIGNS INC RVL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other