BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3180693 · Received June 20, 2013

    Report

    Report Number
    2081283-2013-00001
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Report Date
    March 8, 2013
    Manufacturer
    FREEDOM DESIGNS INC
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COMPLAINT WAS NOT GIVEN TO REGULATORY AFFAIRS FOR PROCESSING UNTIL (B)(6) 2013.

    Description of Event or Problem · 1

    DEALER STATED THAT THE HALF ARM REST ASSEMBLY ON A RVL WHEELCHAIR IS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280788 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR FREEDOM DESIGNS INC RVL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other