BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVELI

    MDR report key: 17302252 · Received July 11, 2023

    Report

    Report Number
    3020889437-2023-00006
    Event Type
    Injury
    Date Received
    July 11, 2023
    Date of Event
    June 14, 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
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT TREATED WITH AVELI PRESENTED WITH A SEROMA APPROXIMATELY ONE MONTH POST-PROCEDURE. AN ESTIMATED VOLUME OF 20CC MAX IN THE LEFT BUTTOCK WAS DRAINED OVER SEVERAL FOLLOW UP VISITS. THE AREA WHERE THE SEROMA WAS OBSERVED WAS REPORTED TO CORRELATE WITH AN AREA TREATED AGGRESSIVELY AS THE PATIENT HAD SEVERAL LARGE DIMPLES IN ONE LOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2256667 AVELI AVELI OUP REVELLE AESTHETICS, INC. 23041401 00850036790006

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Required Intervention