BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVA

    MDR report key: 716520 · Received May 1, 2006

    Report

    Report Number
    MW1038940
    Event Type
    Malfunction
    Date Received
    May 1, 2006
    Date of Event
    April 27, 2006
    Report Date
    April 27, 2006
    Manufacturer
    NOVA ORTHO MED, INC.
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RESIDENT WAS AMBULATING WITH WALKER IN ROOM. RIGHT BACK LEG ON WALKER BROKE AND RESIDENT FELL TO FLOOR. ABRASIONS TO KNEES AND RIGHT HAND. THE WALKER LEG FAILED JUST BELOW THE WELD FOR THE CROSS SUPPORT FOR THE SEAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVA 4 WHEELED WALKER WITH SEAT CRUISER DELUXE ITJ NOVA ORTHO MED, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other