BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3013678 · Received March 20, 2013

    Report

    Report Number
    1531186-2013-01161
    Date Received
    March 20, 2013
    Report Date
    February 20, 2013
    Manufacturer
    KENSTONE METAL
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) TWO REPORTABLE COMPLAINTS WERE CREATED BECAUSE OF DIFFERENT EVENTS DATES WERE REPORTED, AND THE FILE NUMBERS ARE THE FOLLOWING: (B)(4).

    Description of Event or Problem · 1

    (B)(4) THE DEALER REPORTED THAT THE 6895 COMMODE SEAT VINYL CRACKED, WATER GOT INTO THE WOOD, RESULTING IN A BROKEN SEAT. ADDITIONALLY, IT WAS REPORTED THAT THE END USER REPLACED THE SEAT TWICE FOR SIMILAR ISSUE. THE FIRST TIME HAPPENED ON (B)(6) 2012, AND A SECOND TIME ON (B)(6) 2013. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116447 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX KENSTONE METAL 6895

    Patients

    Seq Age Sex Outcome Treatment
    1 Other