BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V-BEAM DUAL SHEER LASER

    MDR report key: 3835725 · Received May 21, 2014

    Report

    Report Number
    MW5036271
    Event Type
    Injury
    Date Received
    May 21, 2014
    Date of Event
    January 4, 2014
    Report Date
    May 13, 2014
    Manufacturer
    CANDELA CORP.
    Product Code
    GEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD A V-BEAM PROCEDURE DONE BY DR (B)(6). DR (B)(6) ASSURED ME THAT THE PROCEDURE WAS SAFE AND SHE HAD PERFORMED IT MANY TIMES ON A VARIETY OF PTS AND INCLUDED HERSELF. SHE ASSURED ME THAT SHE WOULD USE A LOW SETTING WHEN PERFORMING THE LASER TREATMENT. AFTERWARDS I WAS VERY RED AND THEN GRADUALLY TURNED PURPLE. I WAS TOLD THAT THIS WOULD RESOLVE IN 7-10 DAYS AND WHEN IT DID NOT I WENT BACK IN TO GET IT CHECKED OUT AND HER ASSISTANT COULD SEE THE DAMAGE THAT THE LASER CAUSED AS YOU COULD SEE THE MARKS. DR (B)(6) PRETENDED NOT TO SEE THE DAMAGE AND WOULD NOT ADMIT FAULT. SHE STATED THAT SHE DID USE A LOW SETTING AND THE TREATMENT WAS NON-PURPURIC AND BLAMED THE DISCOLORATIONS, DEPRESSIONS, AND LINES ON MY SKIN ON ROSACEA. SHE DID OFFER ME MY MONEY BACK BUT SINCE THEN THE V-BEAM LASER HAS CAUSED WHAT LOOKS LIKE SCARRING ON MY FACE, SEVERELY DRY SKIN, VERTICAL LINES, AND TWO HYPOPIGMENTATION SPOTS THE SIZE OF HALF DOLLARS ON MY CHEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301762 V-BEAM DUAL SHEER LASER NONE GEX CANDELA CORP. DUAL SHEER

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention