BEUDAMED
    FDA Adverse Event Injury Summary report: N

    360 ULTRA EXILIS

    MDR report key: 11349012 · Received February 18, 2021

    Report

    Report Number
    MW5099502
    Event Type
    Injury
    Date Received
    February 18, 2021
    Date of Event
    August 21, 2020
    Report Date
    February 17, 2021
    Manufacturer
    BTL INDUSTRIES, INC.
    Product Code
    GEI
    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 DECIDED TO DO A EXILIS 360 IN MY ABS TO TIGHT MY STOMACH SKIN. I WAS VERY ACTIVE WORKING OUT SO I HAVE MARK MY ABS BUT I WANT TO HAVE MORE TIGHT MY SKIN. I WENT FOR MY FIRST TREATMENT ON (B)(6) 2020 AND RIGHT AFTER I STARTED WITH STOMACH PAIN. I CALLED THE EXILIS BUSINESS AND I ASKED IF THIS WAS SOMETHING TO DO WITH THE EXILIS ABS AND THEY SAID NO. SO I CONTACTED MY DOCTOR AND HE SAID IT COULD BE HEARTBURN AFTER A MONTH OF OMEPRAZOLE. AFTER A MONTH I WAS STILL IN PAIN SO MY DOCTOR SAID THAT PROBABLY WAS ULCERS AND TO CONTINUE TREATMENT. UNTIL (B)(6) 2021 I ASKED MY DOCTOR TO DO AN ENDOSCOPY, THEY TOOK BIOPSIES AS WELL. EVERYTHING CAME OUT NORMAL. THE BIOPSIES SHOW A LITTLE INFLAMMATION. I ASKED THE DOCTOR IF AT SOME POINT I HAVE ULCER IN THE PAST, HE SAID, I COULD. I HAVE NEVER SUFFERED STOMACH PAIN BEFORE THE EXILIS 360. I THINK THIS TREATMENT CAUSE MY PROBLEM THAT MY DOCTOR NOW THINK IS GASTRITIS. I HAVE BEEN WITH STOMACH PAIN SINCE THEN. I HAVE STOP WORKING OUT. AFTER THE FIRST TREATMENT I CONTACT THE BUSINESS AND THEY TOLD ME THE TREATMENT HAS NOTHING DO WITH MY STOMACH AND I HAVE PAID FOR SIX TREATMENT TOTAL FOR MY ABS. FOR SOME REASON THEY DID A TREATMENT ON MY UNDER EYES BAGS , AND THE THIRD ON MY SIDE WAIST. AFTER THAT I CANCEL ALL OF THE REST OF THE TREATMENTS BECAUSE I WAS IN SO MUCH PAIN. I ASKED THEM AGAIN IF THAT HAS SOMETHING TO DO WITH MY PAIN AND THEY SAID NO WHEN I CALL THEM. WHEN I EMAIL THEM I HAVE NOT GET ANY ANSWER FROM THEM. NOW THAT MY ENDOSCOPY AND ULTRASOUND COME NORMAL, I BELIEVE THIS TREATMENT HAS CAUSED MY STOMACH PAIN. I HEARD ON TV AND READ THAT THE FDA APPROVE THIS TREATMENT THAT IS WHY I FEEL COMFORTABLE TRYING IT. I HAD SOME BLOOD TEST SINCE I STARTED WITH THE PAIN AND EVERYTHING CAME NORMAL. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238692 360 ULTRA EXILIS ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BTL INDUSTRIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other