BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENEVEVE

    MDR report key: 7769568 · Received August 8, 2018

    Report

    Report Number
    MW5079010
    Event Type
    Injury
    Date Received
    August 8, 2018
    Date of Event
    April 24, 2018
    Report Date
    August 3, 2018
    Manufacturer
    VIVEVE, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RADIOFREQUENCY "REJUVENATION" PROCEDURE IN DERMATOLOGY OFFICE. NO PAIN OR ADVERSE EFFECTS UNTIL 10-14 DAYS LATER. PAINFUL UPPER ANTERIOR VAGINA IN AREA OF 2001 BLADDER SURGERY, BURNING WITH URINATION, FELT LIKE BLADDER INFECTION STARTING, AND SENSE OF NOT BEING ABLE TO FULLY EMPTY MY BLADDER BEGAN. THIS LASTED FOR THE NEXT 4-6 WEEKS AND HAS FINALLY RESOLVED. I TOOK SOME ANTIBIOTICS NIGHTLY AND HAVE BEEN FINE, 3 MONTHS AFTER THE PROCEDURE. I EXPERIENCED NO BENEFIT AND AM CONCERNED THAT HAD SYMPTOMS NOT GONE AWAY. I WOULD SUFFER A LOT OF REGRET AND MAYBE MORE UTI'S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605773 GENEVEVE ELECTROSURGICAL, CUTTING, AND COAGULATION GEI VIVEVE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR