BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVELI

    MDR report key: 19155321 · Received April 22, 2024

    Report

    Report Number
    3020889437-2024-00003
    Event Type
    Injury
    Date Received
    April 22, 2024
    Date of Event
    March 18, 2024
    Report Date
    April 16, 2024
    Manufacturer
    REVELLE AESTHETICS, INC.
    Product Code
    OUP
    UDI-DI
    00850036790006
    PMA / PMN Number
    K232153
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    A NEGATIVE REVIEW OF AVÉLI WAS WRITTEN ON THE REALSELF.COM ONLINE FORUM FOR PLASTIC SURGERY AND COSMETIC PROCEDURES. THE ALLEGED PATIENT REPORTED THAT THEY HAD THE AVÉLI PROCEDURE AND COMPLAINED OF DIMPLES, INDENTATIONS, AND HARD LUMPS ON THE BUTTOCKS. THE INDIVIDUAL REPORTED A "WEIRD SHAPE LIKE A BAD BBL" BUT THEY DID NOT HAVE A BBL. ANOTHER USER COMMENTED ON THE POST "HI, I WOULD DEFINETLY NOT WORRY. EASIER SAID THAN DONE BUT HONESTLY IT LOOKS LIKE YOU NEED TO HAVE YOUR DOCTOR DRAIN YOUR SEROMA. MY BUTT LOOKED SAGGY AND HEAVY LIKE THAT TOO WHEN I WASN'T WEARING MY COMPRESSION SHORTS. EVERYTHING IS MOSTLY HEALED AND SMOOTH NOW, MY BUTT IS STILL FIRM AND I'M MASSAGING OUT NODULES." THE ORIGINAL POSTER REPLIED "THANK YOU! YOU WERE RIGHT! HE DRAINED IT AND ALREADY LOOKS MUCH BETTER. I APPRECIATE YOU!" THE POST WAS REMOVED THE NEXT DAY FROM THE WEBSITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1408216 AVELI AVELI OUP REVELLE AESTHETICS, INC. UNKNOWN 00850036790006

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Required Intervention