BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3181890 · Received June 21, 2013

    Report

    Report Number
    2081283-2013-00002
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    May 24, 2013
    Manufacturer
    FREEDOM DESIGNS INC
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PROVIDER STATES THE TOP STRAP ON ADJUSTABLE TENSION BACK FOR A RVL WHEELCHAIR HAS BECOME UNSTITCHED FROM ADJUSTER PART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282932 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR FREEDOM DESIGNS INC RVL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other