BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVEVE

    MDR report key: 9539154 · Received December 31, 2019

    Report

    Report Number
    MW5091971
    Event Type
    Injury
    Date Received
    December 31, 2019
    Date of Event
    December 19, 2019
    Report Date
    December 29, 2019
    Manufacturer
    VIVEVE, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    VIVEVE BURNING SENSATION DURING TREATMENT WHICH WAS VERY PAINFUL. THE ENTIRE TIME I WAS SCREAMING WHENEVER I FELT THIS PAIN. THE DOCTOR ADJUSTED THE SETTING BUT IT KEPT DOING IT OVER AND OVER. I¿M NOT SURE IF IT WAS MALFUNCTIONING AND NOTHING WAS PRESENTED THAT SHOWED MACHINE WAS CHECKED PERIODICALLY FOR MAINTENANCE. TREAT MEANT WAS CUT SHORT DUE TO PAIN BUT I STILL PAID 2K. I WON¿T BE DOING THIS AGAIN. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1328621 VIVEVE ELECTROSURGICAL, CUTTING AND COAGULATION AND ACCESSORIES GEI VIVEVE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR