BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANDELA CORP. V BEAM LASER

    MDR report key: 1431475 · Received July 23, 2009

    Report

    Report Number
    MW5012169
    Event Type
    Injury
    Date Received
    July 23, 2009
    Date of Event
    January 19, 2005
    Report Date
    July 23, 2009
    Manufacturer
    CANDELA CORP.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN EARLY 2005, I WENT TO SEE A DR. I WOULD LIKE TO NOTATE THAT THIS WAS ONLY TO BE A CONSULTATION FOR A PREVENTATIVE MEASURE, AS I AM AN ACTRESS AND I WANTED TO MAINTAIN MY GOOD SKIN CONDITION. HOWEVER, DR TURNED THIS INTO A MONEY MAKING OPPORTUNITY AND SOLD ME ON USING THE CANDELA LASER "V BEAM" AND "SMOOTH BEAM" LASERS AT THAT CONSULTATION. HE TOLD ME IT IS A "LUNCHTIME" PROCEDURE AND WOULD NOT DAMAGE OR INJURE MY SKIN AT ALL. THIS WAS A LIE. FURTHER, HE IGNORED THE FDA, AND USED BOTH OF THESE LASERS AT THE SAME SITTING, WHEN THEY WERE NOT APPROVED TO BE USED TOGETHER. THEY ARE TO BE USED SEPARATELY ON SEPARATE APPOINTMENTS. HOWEVER, DR NEVER BOTHERED TO MENTION THIS FACT TO ME WHEN HE OVERBEARINGLY TOLD ME THAT THEY 'BOTH HAD TO BE USED TOGETHER', WHEN I OBJECTED TO HAVING ANYTHING DONE ON MY BEAUTIFUL SKIN ON MY CHEEKS. DR INSISTED ON USING BOTH THE V BEAM AND THE SMOOTH BEAM TOGETHER. THIS IS IN DIRECT VIOLATION OF FDA APPROVAL. THE RESULTS WERE A DISASTER. I HAD SEVERE BRUISING, SWELLING HYPER-PIGMENTATION, AND REDNESS, LIKE I HAD BEEN COOKED LIKE A TOMATO. I WAS IN SEVERE PAIN, LIKE I HAD BEEN BURNT. THE DOCTOR RUSHED OUT OF THE ROOM AND SAID NOTHING. WHEN I CALLED HIM A FEW DAYS LATER TO COMPLAIN VIA PHONE, SINCE MY FACE WAS HURTING AND I COULD NOT WORK - HE WENT INTO A COPY DENIAL. NO FOLLOW UP PROCEDURES OR INSTRUCTIONS WERE GIVEN. I WAS ONLY GIVEN A BILL TO PAY AT THE FRONT DESK AND HAD TO WALK OUT OF THE OFFICE LOOKING LIKE I HAD BEEN MUGGED AND BEATEN. I WAS TOTALLY EMBARRASSED, BUT MORE IMPORTANTLY VERY CONCERNED ABOUT MY PHYSICAL STATE. THIS LASER PROCEDURE SERIOUSLY INJURED MY SKIN. I AM STILL HEALING, FOUR YEARS LATER, FROM THIS ONE TIME EVENT THAT CAUSED ME INJURY. I WOULD LIKE BOTH THIS DOCTOR [WHO HAS VIOLATED YOUR GUIDELINES FOR THE USAGE OF THESE LASERS], AS WELL AS THE CANDELA CORPORATION TO BE INVESTIGATED. THESE ARE DANGEROUS LASERS. DATES OF USE: ONE TIME ONLY, 2005. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED?: NO. CANDELA CORP., V BEAM AND SMOOTH BEAM LASER EARLY 2005, ONE TIME USED IMPROPERLY BY A DR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANDELA CORP. V BEAM LASER NONE GEX CANDELA CORP.
    2 SMOOTH BEAM LASER NONE GEX CANDELA CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other| S