BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMENIS, INC.

    MDR report key: 1237827 · Received November 20, 2008

    Report

    Report Number
    2914019-2008-00062
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    October 20, 2008
    Report Date
    November 6, 2008
    Manufacturer
    LUMENIS. LTD.
    Product Code
    GEX
    PMA / PMN Number
    K020839
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON SITE LUMENIS FIELD SERVICE INVESTIGATION FOUND THAT THE SUBJECT (560NM IPL HEAD) DEVICE WAS WITHIN ALLOWABLE OPERATING AND FUNCTIONAL TOLERANCES. BASED UPON REPORTED SETTINGS POWER LEVELS DURING TREATMENT WERE TOO AGGRESSIVE FOR PATIENT SKIN TYPE AND TREATMENT LOCATION IN CONTRADICTION TO PRODUCT LABELING. NO FAILURE MODE COULD BE FOUND WITH THE SUBJECT DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT SUSTAINED SMALL 1ST TO 2ND DEGREE BURNS, AS A RESULT OF AN IPL TREATMENT TO THE FACE. AMOXIL ANTIBIOTIC WAS PRESCRIBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMENIS, INC. IPL QUANTUM SR GEX LUMENIS. LTD. GAL3697000

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention