BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAPULSE 5000C 117 VAC

    MDR report key: 664283 · Received January 13, 2006

    Report

    Report Number
    2914019-2006-00002
    Event Type
    Injury
    Date Received
    January 13, 2006
    Date of Event
    December 27, 2005
    Report Date
    January 13, 2006
    Manufacturer
    LUMENIS, INC./COHERENT MEDICAL GROUP
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THREE-QUARTERS THROUGH A RESURFACING PROCEDURE, THE CPG PATTERN REVERTED TO A COLLIMATED BEAM (SINGLE SPOT) AND A HOLE ABOUT 2-3 MM IN DEPTH AND 2-3 MM IN DIAMETER WAS DRILLED IN THE PATIENT'S FACE NEAR THE LEFT LOWER LID ORBITAL RIM MARGIN. THE PHYSICIAN REPORTED THAT THE INCIDENT OCCURRED SHORTLY AFTER HE REPOSITIONED THE LASER. THE ULTRAPULSE UNIT/CPG IS A RENTAL UNIT. THE END USER, ARRANGED FOR A SERVICE EVALUATION BY A THIRD PARTY SERVICE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAPULSE 5000C 117 VAC SURGICAL LASERS GEX LUMENIS, INC./COHERENT MEDICAL GROUP MODEL XL5000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR