BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHTSHEER SYSTEM

    MDR report key: 259075 · Received January 12, 2000

    Report

    Report Number
    2914019-2000-00001
    Event Type
    Injury
    Date Received
    January 12, 2000
    Report Date
    December 15, 1999
    Manufacturer
    COHERENT MEDICAL GROUP
    Product Code
    GEX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A NURSE WAS TREATING THE PT'S UPPER PART OF THE EYEBROWS FOR HAIR REMOVAL AND INSTEAD OF AIMING IN THE UPSIDE POSITION, SHE FIRED THE LASER IN THE DIRECTION OF THE EYE. THE PT WAS NOT PROTECTED WITH EYE SHIELDS. THERE WAS AN INJURY TO THE IRIS OF THE EYE, WHICH RESULTED IN RETRACTION. THE PT WAS SENT TO AN OPHTHALMOLOGIST AND TREATED WITH STEROIDS TO REVERSE THE INJURY, BUT THERE WAS NO CHANGE. THERE IS NO VISUAL DEFECT, AND NO CHANGE IN THE VISIBILITY OF THE PT, ACCORDING TO THE DOCTOR. THE IRIS HAS A MALFORMATION WHICH IS PERMANENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTSHEER SYSTEM LASER GEX COHERENT MEDICAL GROUP NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention