BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASHLEY BLACK FASCIABLASTER

    MDR report key: 6537197 · Received April 29, 2017

    Report

    Report Number
    MW5069465
    Event Type
    Injury
    Date Received
    April 29, 2017
    Date of Event
    January 1, 2017
    Report Date
    April 29, 2017
    Manufacturer
    ADB INTERESTS, LLC
    Product Code
    IOD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(6) CLAIMS HER FASCIABLASTER IS FOR GETTING RID OF CELLULITE AND FIXING THE SKIN'S APPEARANCE. MY CELLULITE IS NOW WORSE AND MY SKIN TEXTURE IS SAGGING AND LOOSE IN CERTAIN AREAS. I NOW HAVE SPIDER VEINS. SHE INSTRUCTED US TO USE IT AT A PAIN TOLERANCE LEVEL OF 7 OR 8 OUT OF 10 AND NOW SHE'S TELLING NEW PEOPLE ONLY 3-4. SHE ENCOURAGED US TO GO HARD AND DEEP OVER OUR SKIN. NOW SHE SAYS GO LIGHT AND FAST. SHE IS TESTING ON US WITHOUT US EVEN KNOWING. SOME WOMEN HAVE HAD BLOOD CLOTS AND FACE DROOPING. PLEASE INVESTIGATE THIS PRODUCT AND THE FOUNDER. SHE IS A CONWOMAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314291 ASHLEY BLACK FASCIABLASTER FASCIABLASTER IOD ADB INTERESTS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other