BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMSELLA BTL

    MDR report key: 18399550 · Received December 26, 2023

    Report

    Report Number
    MW5149580
    Event Type
    Injury
    Date Received
    December 26, 2023
    Date of Event
    August 19, 2023
    Report Date
    December 21, 2023
    Manufacturer
    BTL INDUSTRIES JSC
    Product Code
    KPI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I USED BTL MACHINE CALLED EMSELLA. IT DAMAGED MY MUSCLES PERMANENTLY, ENTIRE PELVIC FLOOR, HAM[INVALID], ADDUCTORS AND GLUTES INCLUDING MUSCLES, SMASHING THEM AND INJURING NERVES. THE SIGNAL HAD TRAVELLED AS FAR AS MY HANDS, CHEST, BREAST, NECK, FACE, AND HEAD. IN FACT I AM WORRIED THAT THE ELECTRIC COIL WAS BROKEN AND INSTEAD OF ELECTROMAGNETIC SIGNAL IT WAS DELIVERED ELECTRIC SIGNAL AND ELECTROCUTED MY ENTIRE BODY. ALL MUSCLES SHORTENED SOME WERE INJURED AND BRUISED WHERE THE SIGNAL WAS TAPPING DIRECTLY, ENTIRE VAGINA IS DAMAGED, I HAVE BURNING PAIN INSIDE PELVIS IN VAGINA, IT DAMAGED MY HAM[INVALID], I CANNOT WALK, THIS IS SHAM AND SCAM TECHNOLOGY UNLESS THE PROVIDER USED IT WRONGLY. EAR DISAPPROVE IT. I HAVE USED IT LONDON UK BUT WANT TO WARN YOU ABOUT IT. BTL (I USED IT IN (B)(6). WEAK PELVIC FLOOR MUSCLES WANTED TO IMPROVE BUT DAMAGED ALL MUSCLES FOR LIFE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2266324 EMSELLA BTL STIMULATOR, ELECTRICAL, NON-IMPLANTABLE, FOR INCONTINENCE KPI BTL INDUSTRIES JSC

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Other| S DIAZEPAM FOR RELAXING DAMAGED MUSCLES.| ORAL MORFINE WHICH I HAVE TO USE SINCE THE SHAN TREATMENT.| PARACETAMOL.