BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BURTON

    MDR report key: 443437 · Received February 5, 2003

    Report

    Report Number
    443437
    Event Type
    Malfunction
    Date Received
    February 5, 2003
    Date of Event
    May 22, 2002
    Report Date
    July 24, 2002
    Manufacturer
    BURTON MEDICAL PRODUCTS INC
    Product Code
    KYT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    EXAMINATION WAS BEING PERFORMED ON A PT. THE FREE STANDING EXAM LIGHT WAS REPOSITIONED. THE MECHANICAL STOP FAILED AND THE LAMP SWUNG AROUND AND STRUCK THE PT IN THE EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BURTON EXAMINATION LIGHT KYT BURTON MEDICAL PRODUCTS INC 0224100 *
    2 BURTON EXAMINATION KYT BURTON MEDICAL PRODUCTS INC 0102110 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other