BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMSCULPT

    MDR report key: 8847189 · Received July 30, 2019

    Report

    Report Number
    MW5088569
    Event Type
    Injury
    Date Received
    July 30, 2019
    Date of Event
    May 8, 2019
    Report Date
    July 28, 2019
    Manufacturer
    BTL INDUSTRIES JSC
    Product Code
    NGX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD EMSCULPT PROCEDURE. NURSE TURNED UNIT UPSIDE DOWN TO WORK LOWER ABDOMINAL MUSCLES. I AM (B)(6) YEARS OLD AND WAS MENSTRUATING. HORRIBLE CRAMPS FOLLOWED. HEAVY PERIOD LAST 16 DAYS. HAD TO HAVE ULTRASOUND WHICH LED TO MRI TO EXAMINE MASS AND CYST ON OVARY. MRI REVEALED MORE OF A CYST. THEN F/U WITH ULTRASOUND. WORRIED EMSCULPT MACHINE CAUSES CYST OR COULD CAUSE ENDOMETRIOSIS BY PULLING UTERINE TISSUE INTO FALLOPIAN TUBES OR OVARIES. THIS PRODUCT NEEDS TO BE FULLY EVALUATED TO MAKE SURE IF DOES NOT AFFECT INTERNAL ORGANS. TWO ULTRASOUNDS AND MRI. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634475 EMSCULPT STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING NGX BTL INDUSTRIES JSC

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other