BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVEVE

    MDR report key: 8079588 · Received November 15, 2018

    Report

    Report Number
    MW5081403
    Event Type
    Malfunction
    Date Received
    November 15, 2018
    Date of Event
    August 29, 2018
    Report Date
    November 13, 2018
    Manufacturer
    VIVEVE, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    HAD VAGINAL REJUVENATION USING GENEVEVE FROM VIVEVE. HAD MAJOR DISCOMFORT AND COULD NOT CONTINUE TREATMENT; MACHINE MALFUNCTIONED. COMPANY WANTED TO JUST REPLACE THE DEVICE. PRACTITIONER NO LONGER WISHES TO PERFORM TREATMENT. VIVEVE WILL NOT TAKE MACHINE BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912876 VIVEVE GENEVEVE GEX VIVEVE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR