BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VELASHAPE

    MDR report key: 5053496 · Received August 29, 2015

    Report

    Report Number
    MW5055890
    Event Type
    Injury
    Date Received
    August 29, 2015
    Date of Event
    August 20, 2015
    Report Date
    August 29, 2015
    Manufacturer
    SYNERON
    Product Code
    NUV
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD VELASHAPE BY SYNERON PERFORMED FOR 1/2 HOUR ON THE BACK SIDES OF MY UPPER LEGS. OPERATOR SAID, DRINK LOTS OF WATER AFTERWARDS, TO REMOVE TOXINS. DRIVING HOME, MY STOMACH GOT QUEASY, AND GOT WORSE AS THE DAY PROGRESSED. NEXT DAY, I GOT A HEMORRHOID (NEVER BEFORE HAD THEM). NEXT FEW DAYS, I GOT SEVERAL HEMORRHOIDS. I AM THIN, ATHLETIC, 5'5", (B)(6) CAUC FEMALE, BP AVG 112/69, ALWAYS SOFT, THIN STOOLS. I DO NOT EAT OUT, AND HAVE A VERY LIMITED DIET, THE ONLY CHANGE BEING THE SEALED WATER BOTTLE GIVEN BY PRACTITIONER. THE OPERATOR SAID SYNERON SAID THIS IS NOT A POSSIBLE SYMPTOM. WELL, I KNOW IT IS WHAT CAUSED MY EXCRUCIATINGLY PAINFUL SYMPTOMS. SO I AM NOW REPORTING IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573830 VELASHAPE VELASHAPE NUV SYNERON

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR