BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIXEL8 RF MICRONEEDLING DEVICE

    MDR report key: 20160328 · Received September 5, 2024

    Report

    Report Number
    MW5159285
    Event Type
    Injury
    Date Received
    September 5, 2024
    Date of Event
    January 2, 2024
    Report Date
    September 3, 2024
    Manufacturer
    ROHRER AESTHETICS, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PIXEL8 RADIO FREQUENCY DEVICE CAUSED SEVERE FAT LOSS. VIO MEDPSA IN (B)(6), IN CLAIMS THEY USED "THE LOWEST SETTINGS" BUT WILL NOT TELL ME WHAT SPECIFIC SETTINGS. I LOST SUBSTANTIAL FACIAL FAT AND HAD TO GAIN 30LBS TO PROTECT MY FACE. MY FACE IS SAGGING AND I AM MORTIFIED THAT THIS DEVICE IS LEGALLY BEING USED ON PEOPLE AS EVERYONE I KNOW WHO HAS TRIED THIS - HAS HAD FACIAL FAT LOSS. THERE IS A SUPPORT GROUP ONLINE WITH 25,000 PEOPLE ON IT. MY FACE WOULD BLOW UP LIKE A PUFFER FISH FROM HEAT LIKE THE SAUNA AND MY FACE COULD NOT SWEAT. THE SWEAT WAS STUCK IN MY FACE. THE INFLAMMATION CAME DOWN EVENTUALLY AND WITH THAT ALL OF MY BEAUTIFUL FACIAL FAT. I AM DEVASTATED THIS DEVICE WAS EVER CLEARED BY THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2296595 PIXEL8 RF MICRONEEDLING DEVICE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ROHRER AESTHETICS, INC. PIXEL8-RF

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Other| R STARTED ON COLLAGEN TO HELP BUILD BACK MY LOST FACE.