BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3071925 · Received April 22, 2013

    Report

    Report Number
    1531186-2013-01699
    Date Received
    April 22, 2013
    Report Date
    March 27, 2013
    Manufacturer
    KENSTONE METAL
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    POTENTIAL FOR INJURY ASSOCIATED WITH A BROKEN SEAT ON A MODEL 6895 SHOWER COMMODE CHAIR. THIS EVENT COULD CAUSE POSSIBLE PRODUCT INSTABILITY AND THE POTENTIAL FOR THE USER TO SLIDE OFF, AS WELL AS THE POSSIBILITY OF PHYSICAL INJURY AS A RESULT OF CONTACT WITH THE BROKEN COMMODE SEAT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172231 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX KENSTONE METAL 6895

    Patients

    Seq Age Sex Outcome Treatment
    1 Other