BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMENISONE

    MDR report key: 1022515 · Received April 1, 2008

    Report

    Report Number
    2914019-2008-00005
    Event Type
    Injury
    Date Received
    April 1, 2008
    Date of Event
    February 10, 2008
    Report Date
    April 1, 2008
    Manufacturer
    LUMENIS, LTD.
    Product Code
    GEX
    PMA / PMN Number
    K06448
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE IPL HANDPIECE, 560NM FILTER, SMALL LIGHTGUIDE AND SWITCHING MODULE WERE REQUESTED TO BE SENT TO MFR FOR INVESTIGATION. SHOULD THE ITEMS BE RETURNED AS REQUESTED, A ROOT CAUSE EVALUATION WILL BE CONDUCTED. THE RESULTS WILL BE UPDATED IN A FOLLOW-UP MDR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IPL HANDPIECE FAILED ON THE LUMENIS ONE CAUSING A BURN TO THE PT'S FACE. LUMENIS MADE REASONABLE ATTEMPTS; HOWEVER, NO ADDITIONAL MEDICAL DETAILS WERE MADE AVAILABLE FROM THE USER FACILITY REGARDING THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMENISONE LASER, SURGICAL, FOR USE IN DERMATOLOGY GEX LUMENIS, LTD. LUMENIS ONE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention