BEUDAMED
    FDA Adverse Event Other Summary report: N

    LUMENIS 1

    MDR report key: 821899 · Received February 20, 2007

    Report

    Report Number
    2914019-2007-00006
    Event Type
    Other
    Date Received
    February 20, 2007
    Date of Event
    January 15, 2007
    Report Date
    February 20, 2007
    Manufacturer
    LUMENIS, LTD.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LUMENIS CUSTOMER ENGINEER EVALUATED THE LUMENIS ONE DEVICE AND COULD NOT DUPLICATE ANY PROBLEMS WITH THIS DEVICE. PER THE CE, THE DEVICE WAS WITHIN SPEC AND THE LIGHTSHEER SAPPHIRE TIP WAS CLEAN. THE REPORTED TREATMENT PARAMETERS WERE HIGHER THAN THE RECOMMENDED PARAMETERS FOR THE REPORTED SKIN TYPE; THIS APPEARS TO BE THE ROOT CAUSE OF THE INCIDENT. LUMENIS RECOMMENDED THAT THE CUSTOMER OBTAIN ADD'L TRAINING FROM LUMENIS. THE PHYSICIAN WAS ALSO REFERRED TO THE LUMENIS PHYSICIAN RECOMMENDED PARAMETERS, A COPY OF WHICH WAS PROVIDED TO THE PHYSICIAN.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED THAT A PT HAD BURNS TO THE CHEEK FOLLOWING TREATMENT WITH THE LIGHTSHEER HEAD AT 19J, AUTO. THE PHYSICIAN STATED THAT HE CALIBRATED THE SYSTEM PRIOR TO THIS TREATMENT. ON 1/17/07 THE PHYSICIAN REPORTED THAT THE PT HAD BEEN GIVEN PRESCRIPTION MEDICATION (4% HYDROCORTISONE CREAM FOR 7 DAYS) FOR THE BURNS. ON THE SAME DAY, THE COMPLAINT WAS DETERMINED TO BE REPORTABLE BASED ON THIS NEW INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMENIS 1 COMBINATION INTENSE PULSE LIGHT DEVICE AND SOLID STATE LASER GEX LUMENIS, LTD. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention NONE REPORTED