BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVELI

    MDR report key: 17301983 · Received July 11, 2023

    Report

    Report Number
    3020889437-2023-00005
    Event Type
    Injury
    Date Received
    July 11, 2023
    Date of Event
    June 19, 2023
    Report Date
    July 11, 2023
    Manufacturer
    REVELLE AESTHETICS, INC.
    Product Code
    OUP
    UDI-DI
    00850036790006
    PMA / PMN Number
    K221336
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT PRESENTED WITH NUMEROUS CELLULITE DEPRESSIONS, SOME IN CLOSE PROXIMITY TO ONE ANOTHER. THE CELLULITE DEPRESSIONS WERE TREATED WITH AVELI. LIPO 360 AND FAT GRAFTING WERE ALSO PERFORMED IN OTHER AREAS. THE PATIENT PRESENTED WITH SEROMAS ON BOTH BUTTOCKS AND AN AREA IN THE BUTTOCKS DESCRIBED AS "SEPARATION OR DETACHED FEELING" APPROXIMATELY 2 WEEKS POST PROCEDURE. THE PATIENT HAS BEEN USING COMPRESSION AS DIRECTED. ON BOTH BUTTOCKS HUNDREDS OF CC'S OF FLUID WERE DRAINED (TOTAL) OVER 3-4 FOLLOW-UP VISITS. THE LAST VISIT WAS ABOUT 80 CC'S TOTAL FROM BOTH BUTTOCKS. ULTRASOUND AT THE LAST VISIT CONFIRMED THE FLUID WAS GONE AFTER THE LAST DRAINING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2148750 AVELI AVELI OUP REVELLE AESTHETICS, INC. 23041701 00850036790006

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Required Intervention