BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVEVE SYSTEM

    MDR report key: 7073497 · Received November 30, 2017

    Report

    Report Number
    3013565579-2007-00001
    Event Type
    Injury
    Date Received
    November 30, 2017
    Date of Event
    November 2, 2017
    Report Date
    November 30, 2017
    Manufacturer
    VIVEVE, INC.
    Product Code
    GEI
    PMA / PMN Number
    K162547
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    VIVEVE DOES NOT BELIEVE THIS MEETS THE CRITERIA FOR A REPORTABLE EVENT PER THE FDA MEDICAL DEVICE REPORTING FOR MANUFACTURERS, GUIDANCE ISSUED JULY 9, 2013. VIVEVE IS REPORTING FOR COMPLETENESS. PRODUCT WAS RETURNED NOVEMBER 16, 2017 AND AN INVESTIGATION HAS BEEN INITIATED. (B)(6) 2017 - TREATING PHYSICIAN REPORT: THERE WAS A POPPING NOISE WHEN ONE OF THE 220 PULSES WAS DELIVERED THAT CAUSED PATIENT TO JUMP; PATIENT WAS IN A LOT OF PAIN FOR A COUPLE OF SECONDS. TREATMENT WAS FINISHED WITH NO OTHER ISSUES. PATIENT SAID THAT SHE WAS DOING FINE AFTER TREATMENT, BUT CALLED THE NEXT DAY SAYING THAT SHE HAD A LOT OF PAIN. PATIENT CAME IN ON (B)(6) 2017 FOR AN EVALUATION. PER TREATING PHYSICIAN, THERE WERE NO OTHER SYMPTOMS; EXAM LOOKED AND FELT NORMAL; PATIENT WAS VERY TENDER WITH SPECULUM, PAIN SEEMED GENERALIZED; COULD NOT DETERMINE WHERE THE PAIN WAS COMING FROM PATIENT SAW HER OB/GYN ON (B)(6) 2017 AND EXAM WAS NORMAL, BUT GAVE HER A SUPPOSITORY FOR THE PAIN. (B)(6) 2017 - PATIENT REPORTED: "FELT LIKE A SURGE OF ELECTRICITY WENT THROUGH MY WHOLE BODY..." "WHEN TREATMENT WAS OVER MY VAGINA FELT HOT AND AS THE DAY PROGRESSED THE HEAT WENT AWAY AND I BEGAN TO FEEL PAIN THAT FELT LIKE FIRE ANT BITES THROUGHOUT MY VAGINA" PRESCRIBED LIDOCAINE, AND TRIED PUTTING ICE "DOWN THERE", BUT NEITHER HELPED. EXAMINED BY HER GYNECOLOGIST ON (B)(6) 2017 - GYNECOLOGIST SAID TISSUE LOOKS OK. NO BLOOD OR DISCHARGE FROM VAGINA. "FEELS LIKE THE WHOLE VAGINA HAS A BAD SUNBURN." PAIN HAS NOT IMPROVED SINCE THE DAY OF THE TREATMENT. AS OF THE TIME OF THIS REPORT, PATIENT HAS REFUSED TO SHARE MEDICAL RECORDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850879 VIVEVE SYSTEM ELECTRO SURGICAL GEI VIVEVE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other