BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENUS BLISS MAX

    MDR report key: 23170396 · Received September 29, 2025

    Report

    Report Number
    MW5176753
    Event Type
    Injury
    Date Received
    September 29, 2025
    Date of Event
    September 13, 2025
    Report Date
    September 25, 2025
    Manufacturer
    VENUS CONCEPT INC.
    Product Code
    PKT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I WAS ON THE 2ND OF 3 SESSIONS ON THE VENUS BLISS LASER LIPO (LIPOLYSIS) AT ()B()6 BUT THIS TIME WITH A DIFFERENT TECHNICIAN AND SUFFERED A TERRIBLE BURN. ITS FDA CLEARED AND ADVERTISED ON THEIR SITE AS "THE TREATMENT IS SAFE, AND COMFORTABLE, AND REQUIRES NO RECOVERY TIME. VENUS BLISS MAX/EMS (ELECTRICAL MUSCLE STIMULATION) CAN HELP YOU ACHIEVE A MORE TONED AND YOUTHFUL APPEARANCE WITHOUT SURGERY OR DOWNTIME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1772979 VENUS BLISS MAX LASER FOR DISRUPTION OF ADIPOCYTE CELLS FOR AESTHETIC USE PKT VENUS CONCEPT INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Other CARBAMAZEPINE | FLUVOXAMINE | MULTI-VITAMIN| TOPIRAMATE