BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVELI

    MDR report key: 19016503 · Received April 1, 2024

    Report

    Report Number
    3020889437-2024-00002
    Event Type
    Injury
    Date Received
    April 1, 2024
    Date of Event
    March 4, 2024
    Report Date
    March 26, 2024
    Manufacturer
    REVELLE AESTHETICS, INC.
    Product Code
    OUP
    UDI-DI
    00850036790006
    PMA / PMN Number
    K232153
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    117

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 22 CELLULITE DEPRESSIONS WERE TREATED WITH AVELI, AND, APPROXIMATELY 4 WEEKS AFTER THE PROCEDURE, 30 CC'S OF FLUID WERE DRAINED FROM A SEROMA ON THE BUTTOCKS. IT WAS REPORTED THAT THREE DAYS LATER, 25 CC'S OF FLUID WERE DRAINED FROM A LARGER SEROMA ON THE BUTTOCKS, AND A FEW SMALL AREAS WERE DRAINED ON THE POSTERIOR SIDE. NODULES WERE ALSO REPORTED AND ARE DISSIPATING WITH MASSAGE AS OF ONE MONTH POST PROCEDURE. SIGNIFICANT BRUISING WAS REPORTED ON DAY 2 AFTER THE AVELI TREATMENT. COMPRESSION GARMENTS WERE WORN FOR TWO WEEKS AFTER THE PROCEDURE. THE BRUISING IS REPORTED TO BE ONGOING APPROXIMATELY ONE MONTH AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1867262 AVELI AVELI OUP REVELLE AESTHETICS, INC. NC83823002 00850036790006

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Required Intervention