BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHTSHEER XC

    MDR report key: 9005753 · Received September 12, 2019

    Report

    Report Number
    3004135191-2019-00107
    Event Type
    Injury
    Date Received
    September 12, 2019
    Report Date
    September 12, 2019
    Manufacturer
    LUMENIS LTD.
    Product Code
    GEX
    PMA / PMN Number
    K170179
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS INVESTIGATED THE REPORTED EVENT BY CONTACTING THE USER FACILITY DIRECTLY. THREE (3) ATTEMPTS HAVE BEEN MADE BY PHONE TO OBTAIN; PATIENT TREATMENT SETTINGS, PATIENT INFORMATION, PATIENT PHOTOS, WHICH WERE PROVIDED, EXCEPT FOR PATIENT'S PHOTOS. A REVIEW OF SUBJECT DEVICE SERVICE RECORDS REVEALED THAT THE DEVICE WAS INSTALLED AT THE FACILITY ON DEC 2005, AND HAS BEEN SERVICED BY LUMENIS ON DEC 2018. THE FACILITY WAS OFFERED TO EVALUATE THE DEVICE AFTER THE ADVERSE EVENT BUT REFUSED. A LUMENIS HEALTHCARE PROFESSIONAL AND CLINICAL TRAINER CONCLUDED " I RECEIVED A CALL FROM DR. (B)(6) ON (B)(6) 2019 . HE ASKED IF I'VE EVER HEARD OF A PATIENT HAVING A DEEP VEIN THROMBOSIS (DVT) FOLLOWING A LASER HAIR REMOVAL TREATMENT. I LET HIM KNOW IN MY 18 YEARS OF WORKING WITH THE LIGHT SHEER DEVICE I HAVE NOT EXPERIENCED OR HEARD OF THIS. I THEN SENT AN ADVERSE EVENT FORM TO HIM AND REQUESTED HIM TO FILL IT OUT. THIS TREATMENT WAS THE THIRD TREATMENT RECEIVED BY THIS PATIENT. PT IS A (B)(6) Y/O SKIN TYPE II PATIENT BEING TREATED IN THE AXILLA FOR. BROWN MEDIUM COARSE HAIR. SHE WAS TREATED WITH THE XC CHILL TIP. A TEST SPOT WAS DELIVERED PRIOR TO FULL TREATMENT. THE SETTINGS WERE 26J/CM 2 30 MS 805 NM WAVELENGTH. THE CLINICIAN REPORTS NO BLISTERS BRUISING OR TENDERNESS DURING TREATMENT. BILATERAL AXILLA TREATED, UNILATERAL DVT REPORTED. SHE REPORTED HAVING A DVT TWO DAYS LATER. PT DENIES ANY MEDICATION, OR HEALTH CONCERNS PRIOR. DEVICE WAS SERVICED IN DECEMBER OF 2018. I HAVE PERSONALLY NOT HEARD ABOUT THIS OCCURRING AS A PROVIDER OF THE LS DEVICE. I HAVE REACHED OUT TO OUR GLOBAL CLINICAL LEADERSHIP AND WILL AMEND THIS REPORT IF ADDITIONAL INFORMATION COMES FORWARD. THE LUMENIS HEALTHCARE PROFESSIONAL AND CLINICAL TRAINER DETERMINED THE INJURY WITH 'MODERATE' SEVERITY (RANKED WITH 6). WHILE THE INFORMATION RECEIVED TO DATE DOES NOT CONFIRM THAT A MALFUNCTION HAD OCCURRED, THE INJURY WAS DEFINED AS 'MODERATE' , THE COMPANY IS REPORTING THE EVENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE COMPLAINT RECORD WILL BE UPDATED ACCORDINGLY, AND A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT ONE (1) PATIENT SUSTAINED A BURN TO THE CHEST AREA (AXILLA) FOLLOWING TREATMENT WITH LUMENIS LIGHTSHEER XC LASER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800072 LIGHTSHEER XC INTENSE PULSE LIGHT DELIVERY DEVICE GEX LUMENIS LTD. LIGHTSHEER XC

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other