BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMSCULPT

    MDR report key: 12925074 · Received December 2, 2021

    Report

    Report Number
    MW5105761
    Event Type
    Injury
    Date Received
    December 2, 2021
    Date of Event
    October 26, 2021
    Report Date
    December 1, 2021
    Manufacturer
    BTL INDUSTRIES, JSC.
    Product Code
    NGX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAD REGULAR CYCLES UNTIL I RECEIVED EMSCULPT TREATMENTS ON MY ABDOMEN. I HAVE A 26 DAY CYCLE. I HAD 1 30 MINUTE TRIAL SESSION AND THEN 4, 1 HOUR SESSIONS IN THE MONTH OF (B)(6) 2021 (1 SESSION PER WEEK). MY LAST NORMAL CYCLE WAS (B)(6) 2021; I WAS EXPECTING A PERIOD ON (B)(6) 2021, BUT IT NEVER CAME. THE SAME FOR (B)(6), WHICH SHOULD HAVE ARRIVED (B)(6) 2021. I HAVE NOT HAD A CYCLE SINCE (B)(6) 2021 AND HAVE BEEN EXPERIENCING HOT FLASHES. THUS FAR, I HAVE MISSED 2 PERIODS (B)(6). I RECOGNIZE THAT I AM OF MENOPAUSE AGE AND PERHAPS IT IS A COINCIDENCE, BUT I HAD NO SYMPTOMS OR INDICATIONS MY CYCLES WOULD END PRIOR TO THE EMSCULPT TREATMENTS. I BELIEVE IT IS A CASE OF OVARIAN FAILURE AS A CONSEQUENCE OF THESE TREATMENTS GIVEN THE SUDDEN ONSET AND NO OTHER SYMPTOMS PRIOR. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1816623 EMSCULPT STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING NGX BTL INDUSTRIES, JSC.
    1816624 EMSCULPT STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING NGX BTL INDUSTRIES, JSC.
    1816625 EMSCULPT STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING NGX BTL INDUSTRIES, JSC.
    1816626 EMSCULPT STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING NGX BTL INDUSTRIES, JSC.
    1816627 EMSCULPT STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING NGX BTL INDUSTRIES, JSC.

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Disability| O