BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASER SCOPE KTP/532 12 AMP

    MDR report key: 8785530 · Received July 11, 2019

    Report

    Report Number
    MW5088060
    Event Type
    Injury
    Date Received
    July 11, 2019
    Date of Event
    March 19, 2019
    Report Date
    June 19, 2019
    Manufacturer
    LASER SCOPE / AMERICAN MEDICAL SYSTEMS INNOVATION CENTER / BOSTON SCIENTIFIC CORP.
    Product Code
    GEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    BURNS CAUSED BY LASER TO LEFT LEG. LASER DID NOT REMOVE SUN / AGE SPOTS TO UPPER TORSO. ON (B)(6) 2019 I HAD LASER TREATMENT FOR REMOVING SUN / AGE SPOTS FROM LEFT LEG. THE TREATMENT WAS EXTREMELY PAINFUL. I COULD SMELL FLESH BURNING. I HAD, JUST PREVIOUS TO THIS, LASER REMOVAL ON UPPER TORSO TO REMOVE AGE / SUN SPOTS. THE LASER TREATMENT DIDN'T WORK AND SPOTS ARE STILL VISIBLE. THE LASER TREATMENT TO THE LEG CAUSED MY LEG TO SWELL, BURNING FOR TWO WEEKS AND WATER RUNNING DOWN MY LEG. THEN SCABS FORMED AND FINALLY FELL OFF LEAVING DEEP TISSUE SCARING. A FEW SPOTS STILL HAVE THE SCAB THAT APPEARS TO BE STUCK TO MY SKIN. I KEPT MY LEG ELEVATED AND APPLIED VASELINE SEVERAL TIMES A DAY. IN MY OPINION, BECAUSE THIS PARTICULAR LASER WAS USED BOTH ON UPPER TORSO AND LEFT LEG RESULTING IN DIFFERENT OUTCOMES AS EXPLAINED ABOVE, THIS MACHINE IS MALFUNCTIONING. ALSO NEEDS TO BE REPLACED DUE TO AGE, I SHOULD HAVE TO THINK THAT THE HEALTH PROFESSIONAL GIVING THIS TREATMENT DID NOT KNOW THAT THEY WERE DOING. VOLTAGE 120AK EST. 2/2004, MANUFACTURED 12/1998. DATES OF USE: (B)(6) 2019 BY LASER. DIAGNOSIS OR REASON FOR USE: REMOVING AGE / SUN SPOTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577198 LASER SCOPE KTP/532 12 AMP POWERED LASER SURGICAL INSTRUMENT GEX LASER SCOPE / AMERICAN MEDICAL SYSTEMS INNOVATION CENTER / BOSTON SCIENTIFIC CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other