BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIXEL8-RF

    MDR report key: 20785962 · Received November 26, 2024

    Report

    Report Number
    3031944951-2024-00001
    Event Type
    Injury
    Date Received
    November 26, 2024
    Date of Event
    December 21, 2023
    Report Date
    November 26, 2024
    Manufacturer
    ROHRER AESTHETICS, INC.
    Product Code
    GEI
    UDI-DI
    00086056400033
    PMA / PMN Number
    K180654
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF TREATMENT ACCORDING TO TREATING FACILITY WAS (B)(6) 2023, NOT (B)(6) 2024 AS INDICATED BY INITIAL REPORTER. A FOLLOW UP APPOINTMENT WAS (B)(6) 2024, WHERE IT WAS INDICATED THAT TREATMENT RESULTS WERE AS EXPECTED. PATIENT/INITIAL REPORTER CONTINUED TO HAVE VARIOUS TREATMENTS FROM THE USER FACILITY UP UNTIL (B)(6) 2024. ALTHOUGH (B)(6) 2023 WAS THE ONLY TREATMENT WITH THIS DEVICE. TREATMENT WAS DONE BY A HEALTHCARE PROFESSIONAL (NURSE PRACTICIONER) THAT HAD BEEN TRAINED AND WELL VERSED IN THE TREATMENT. BEFORE AND AFTER PICTURES HAVE BEEN OBTAINED, AS LATE AS AUGUST 2024. USER FACILITY DID NOT REPORT THE INCIDENT, AS IT DID NOT MEET THE REQUIREMENT FOR A SERIOUS EVENT. DEVICE FUNCTIONED AS INTENDED AND RESULTS WERE AS EXPECTED. DEVICE WAS NOT RETURNED TO THE FACILITY, BECAUSE THERE HAS BEEN NO MALFUNCTION OF THE DEVICE. THIS DEVICE HAS BEEN USED ON AN AVERAGE OF 5-10 TIMES A WEEK WITHOUT INCIDENT. IT IS MY OPINION THAT THIS CASE IS CLOSED AND DOES NOT NEED FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    FDA NOTIFED ROHRER AESTHETICS OF A VOLUNTARY MEDWATCH FORM SUBMITTED BY A PATIENT. AS DESCRIBED ON THE MEDWATCH FORM MW5159285. "FIXEL8 RADIO FREQUENCY DEVICE CAUSED SEVERE FAT LOSS. VIO MEDSPA IN CLAIMS THEY USED "THE LOWEST SETTINGS" BUT WILL NOT TELL ME WHAT SPECIFIC SETTINGS. I LOST SUBSTANTIAL FACIAL FAT AND HAD TO GAIN 30 LBS 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
    2384217 PIXEL8-RF RF MICRONEEDLING GEI ROHRER AESTHETICS, INC. PIXEL8 RF 00086056400033

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Required Intervention PIXEL8 RF SERIAL NUMBER (B)(6)