BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVEVE

    MDR report key: 7742518 · Received August 1, 2018

    Report

    Report Number
    MW5078780
    Event Type
    Injury
    Date Received
    August 1, 2018
    Date of Event
    September 15, 2017
    Report Date
    July 30, 2018
    Manufacturer
    VIVEVE INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD VAGINAL REJUVENATION PROCEDURE WITH RF DEVICE CALLED VIVEVE. I WAS FORCED TO DO PROCEDURE SINCE I WORKED FOR THE COMPANY. SINCE THEN I HAVE HAD NUMBNESS IN MY VAGINAL AREA. I HAD TO GO TO THE GYN ON 10 DIFFERENT OCCASIONS AND WAS PUT ON MEDICATION. DURING THE PROCEDURE, I WAS BURNED AND TOLD THAT IT WAS NORMAL. I REPORTED MY ISSUES TO MY CLINICAL PARTNER. I EVEN EMAILED OUR CLINICAL DEPT WHICH TOLD ME I MUST BE LOW ON TESTOSTERONE. I MADE NUMEROUS REPORTS TO COMPLIANCE AND OUR VP OF SALES WHICH WENT IGNORED. I HAD MANY PHYSICIANS HAVE PTS THAT COMPLAINED OF ISSUES AFTER PROCEDURE. NO FOLLOW UPS WERE MADE TO PHYSICIAN OR PT. I LEFT COMPANY BECAUSE I DID NOT AND DO NOT FEEL THIS IS SAFE FOR WOMEN VIVEVE PROMOTES FOR WOMEN WITH BREAST CANCER AND IS TAKING ADVANTAGE OF THE MESH RECALLS FOR VAGINAL CUFF PROVIDERS. I HOPE THAT THE FDA TAKES A STRONGER STANCE AGAINST THESE AESTHETIC DEVICE WHICH ARE PROMOTED OFF LABEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580140 VIVEVE ELECTROSURGICAL, CUTTING AND COAGULATION GEI VIVEVE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention