BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIGHTSHEER ET

    MDR report key: 801917 · Received January 3, 2007

    Report

    Report Number
    2914019-2005-00084
    Event Type
    Other
    Date Received
    January 3, 2007
    Date of Event
    June 21, 2005
    Report Date
    January 3, 2007
    Manufacturer
    LUMENIS, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE LUMENIS SERVICE DEPOT, THERE WAS A SPOT ON THE OUTSIDE OF THE CHILL TIP. THE ENERGY OUTPUT WAS ALSO ABOVE SPECIFICATIONS AT 10J, 100MS. IT APPEARS THAT THIS FOREIGN MATERIAL CONTAMINATION IS THE ROOT CAUSE OF THE INCIDENT. THE ELEVATED ENERGY OUTPUT MAY ALSO HAVE CONTRIBUTED TO THE ROOT CAUSE; IT IS NOT POSSIBLE TO DETERMINE THE RELATIVE CONTRIBUTION OF THE ELEVATED ENERGY OUTPUT TO THE ROOT CAUSE. THE SERVICE DEPOT CLEANED THE SPOT ON THE CHILL TIP AND RECALIBRATED THE DEVICE. SERVICE DEPOT ADVISED THE CUSTOMER THAT THE CHILL TIP MUST BE KEPT CLEAN AT ALL TIMES TO ENSURE PROPER CALIBRATION AND TO AVOID ADVERSE REACTIONS. (SAME AS PRIOR TREATMENT). BURNING SENSATION. SAW HER NEXT DAY. RED DOTS ALL OVER, 2-3 BLISTERS. LEFT ANTERIOR SIDE-INITIALLY LOOKED LIKE PERIFOLLOICULAR EDEMA, BUT LATER SEEMED TO BLISTER, RED DOTS IN 3 ROWS MODERATELY DARK, USED TOPICAL STEROIDS. SO DR TURNED DOWN TO 22 J, AND TREATED THE REST OF THE LEG WITH NO INJURIES.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE SYSTEM SEEMED TO BE RUNNING HOTTER THAN THE SETTING AND 3 PTS EXPERIENCED BLISTERING AND MODERATE REDNESS. PER THE PHYSICIAN, THE BURNS WERE FIRST DEGREE. AT LEAST ONE OF THE PTS HAD PREVIOUS LIGHTSHEER HAIR REMOVAL TREATMENTS. PER THE PHYSICIAN, TWO OF THE 3 PTS WERE GIVEN TOPICAL STEROIDS, AND ALL OF THE PTS WERE IMPROVING.

    Description of Event or Problem · 2

    CUSTOMER REPORTED THAT THE SYSTEM SEEMED TO BE RUNNING HOTTER THAN THE SETTING AND 3 PTS EXPERIENCED BLISTERING AND MODERATE REDNESS. PER THE PHYSICIAN, THE BURNS WERE FIRST DEGREE. AT LEAST ONE OF THE PTS HAD PREVIOUS LIGHTSHEER HAIR REMOVAL TREATMENTS. PER THE PHYSICIAN, TWO OF THE 3 PTS WERE GIVEN TOPICAL STEROIDS, AND ALL OF THE PTS WERE IMPROVING.

    Description of Event or Problem · 3

    CUSTOMER REPORTED THAT THE SYSTEM SEEMED TO BE RUNNING HOTTER THAN THE SETTING AND 3 PTS EXPERIENCED BLISTERING AND MODERATE REDNESS. PER THE PHYSICIAN, THE BURNS WERE FIRST DEGREE. AT LEAST ONE OF THE PTS HAD PREVIOUS LIGHTSHEER HAIR REMOVAL TREATMENTS. PER THE PHYSICIAN, TWO OF THE 3 PTS WERE GIVEN TOPICAL STEROIDS, AND ALL OF THE PTS WERE IMPROVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTSHEER ET LIGHTSHEER GEX LUMENIS, INC. 50-05345 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other NONE REPORTED.
    2 * Other
    3 * Other