BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMENIS ONE

    MDR report key: 1022687 · Received April 1, 2008

    Report

    Report Number
    2914019-2008-00010
    Event Type
    Malfunction
    Date Received
    April 1, 2008
    Date of Event
    January 22, 2008
    Report Date
    April 1, 2008
    Manufacturer
    LUMENIS LTD.
    Product Code
    GEX
    PMA / PMN Number
    K060448
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TREATMENT HEAD INVOLVED IS BEING RETURNED TO MANUFACTURING SITE FOR EVALUATION. WHEN REPORT IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED WITH ROOT CAUSE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PATIENT HAD EXPERIENCED BLISTERING AND BURNS AFTER IPL TREATMENT. PATIENT IS SKIN TYPE II, AND WAS BEING TREATED FOR TAGLIATEGA, AGE SPOTS, AND ROSACIA. AESTHETICIAN HAD CALIBRATED SYSTEM PRIOR TO TREATMENT AND USED PRIOR SETTINGS. MEDICAL INTERVENTION CONSISTED OF CLOBETASOL, STEROID CREAM AND ALOE VERA. PATIENT'S FACE AND NECK HAVE NEARLY COMPLETELY HEALED; TREATMENT MARKS CONTINUE TO FADE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention