BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENEVEVE

    MDR report key: 7742801 · Received August 1, 2018

    Report

    Report Number
    MW5078794
    Event Type
    Injury
    Date Received
    August 1, 2018
    Date of Event
    March 23, 2017
    Report Date
    July 30, 2018
    Manufacturer
    VIVEVE, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I RECEIVED THE GENEVEVE TREATMENT WHICH IS A RF DEVICE VAGINAL REJUVENATION TREATMENT MADE BY VIVEVE, INC. WITHIN A FEW DAYS OF THE TREATMENT, MY VAGINA FELT NUMB AND STILL DOES. IT ALSO HAS A CONSTANT BURNING SENSATION NEAR THE INTERNAL AREA RIGHT PAST MY INTROITUS. IT'S BEEN 16 MONTHS AND I NO LONGER ENJOY VAGINAL INTERCOURSE BECAUSE OF THE NUMB SENSATION AND CONSTANT BURNING FEELING. THEY PROMOTE IT FOR VAGINAL REJUVENATION, LAXITY, DRYNESS AND DESIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580098 GENEVEVE ELECTROSURGICAL CUTTING AND COAGULATION DEVICE GEI VIVEVE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other