BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENUS VIVA

    MDR report key: 23497553 · Received November 7, 2025

    Report

    Report Number
    MW5178619
    Event Type
    Injury
    Date Received
    November 7, 2025
    Date of Event
    October 31, 2025
    Report Date
    November 3, 2025
    Manufacturer
    VENUS CONCEPT INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PR, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2025 I WAS SUBMITTED TO A TREATMENT USING VENUS VIVA RF EQUIPMENT. THE NEXT DAY I WOKE UP WITH MODERATE FACIAL SWELLING, ESPECIALLY IN THE CHEEK AREA. ON THE SECOND DAY, MY EYES AND THE AREA AROUND MY MOUTH BECAME SWOLLEN. I HAD TO SEEK MEDICAL ATTENTION BECAUSE I WAS AFRAID IT MIGHT AFFECT MY BREATHING. THIS WAS MY FIRST SESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186148 VENUS VIVA ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI VENUS CONCEPT INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Other PREDNISONE.| ZYRTEC.