BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BTL ULTRAFEMME 360

    MDR report key: 8199563 · Received December 26, 2018

    Report

    Report Number
    MW5082613
    Event Type
    Injury
    Date Received
    December 26, 2018
    Date of Event
    September 17, 2018
    Report Date
    December 24, 2018
    Manufacturer
    BTL INDUSTRIES, INC.
    Product Code
    NUV
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I AM (B)(6) AND I DO NOT SPEAK ENGLISH WELL, SO I AM TRYING TO EXPLAIN THE PROBLEM. A (B)(6) GYNECOLOGIST RECOMMENDED TO ME TO USE THE USE OF RADIOFREQUENCY BTL ULTRAFEMME 360 INSIDE MY VAGINA TO IMPROVE MY SEXUAL RELATIONS. 24 HOURS AFTER THE FIRST SESSION, I STARTED TO FEEL A CHRONIC PAIN IN MY BELLY LIKE PERMANENT MUSCLE CONTRACTIONS. THE GYNECOLOGIST DOES NOT KNOW WHAT IS HAPPENING TO ME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1034214 BTL ULTRAFEMME 360 MASSAGER, VACUUM, LIGHT INDUCED HEATING NUV BTL INDUSTRIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Disability