BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMSCULPT

    MDR report key: 10513807 · Received September 9, 2020

    Report

    Report Number
    MW5096497
    Event Type
    Injury
    Date Received
    September 9, 2020
    Date of Event
    July 20, 2020
    Report Date
    September 4, 2020
    Manufacturer
    BTL INDUSTRIES JSC
    Product Code
    IPF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I USED AN EMSCULPT DEVICE PER PROTOCOL AND SUBSEQUENTLY DEVELOPED OVARIAN FAILURE AND MENOPAUSE AT THE AGE OF (B)(6) YR OLD DUE TO THE HIGH INTENSITY ELECTROMAGNETIC WAVES USED BY THIS MACHINE. I HAD A FULLY FUNCTIONING NORMAL CYCLES AND SUDDENLY DEVELOPED MENOPAUSAL STAMP YIN'S. I PURSUED MUCH TESTING TO EVALUATE IF THERE WAS AN ORGANIC CAUSE FOR THIS OVARIAN FAILURE BUT ALL TESTING WAS NORMAL AND MY ONLY EXPOSURE WAS TO THIS DEVICE. I AM THIN AND THE DEVICE WAS DIRECTLY ON MY OVARIES. I HAVE ALLOW SINCE FOUND MANY STUDIES THAT REPORT OVARIAN INJURY AND FAILURE AND RATS AFTER HIGH INTENSITY ELECTROMAGNETIC WAVES; PELVIC ULTRASOUND. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970455 EMSCULPT STIMULATOR, MUSCLE, POWERED IPF BTL INDUSTRIES JSC

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Disability