BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORTHO NOVA

    MDR report key: 1001428 · Received February 21, 2008

    Report

    Report Number
    MW5005598
    Event Type
    Other
    Date Received
    February 21, 2008
    Report Date
    February 21, 2008
    Manufacturer
    NOVA ORTHOMED
    Product Code
    IOR
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT CALLED TO REPORT ON THIS DEFECTIVE PRODUCT STATING THAT THE WHEEL WHICH IS TOO HIGH ON THE FRAME CAUSED HER TO FALL. SHE CONTACTED MFR REQUESTING TO REPLACE THE ENTIRE WHEELCHAIR, BUT THEY SENT HER ONLY THE WHEEL/TIRE AND ASKED HER TO REPLACE IT ON HER OWN. SHE SAID THEY SENT HER THE SAME MODEL AND THIS ONE HAD SAME PROBLEM AND CAUSED HER TO FALL AGAIN. SHE BELIEVED THAT THIS DEVICE IS VERY DANGEROUS AND MFR DOESN'T CARE ABOUT IT. THE WHEELCHAIR WAS BOUGHT FROM WALL GREENS. SHE STATED IN THE MANUAL OF INSTRUCTION IT IS SAID THAT ANY PART REPLACEMENT. SHOULD BE DONE BY A QUALIFIED TECH, BUT "THEY SENT ME THE TIRE TO CHANGE IT BY MYSELF".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO NOVA WHEELCHAIR IOR NOVA ORTHOMED 5060

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR