BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVELI

    MDR report key: 15117895 · Received July 27, 2022

    Report

    Report Number
    3020889437-2022-00004
    Event Type
    Injury
    Date Received
    July 27, 2022
    Date of Event
    June 21, 2022
    Report Date
    July 27, 2022
    Manufacturer
    REVELLE AESTHETICS, INC.
    Product Code
    OUP
    UDI-DI
    00850036790006
    PMA / PMN Number
    K212399
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT TREATED WITH AVÉLI DEVELOPED A SEROMA. THE SEROMA WAS DRAINED 6, 16, AND 21 DAYS AFTER THE PROCEDURE. THE PHYSICIAN WILL CONTINUE DRAINING AND WILL RECOMMEND 24/7 COMPRESSION. THE PHYSICIAN DID NOT RESPOND TO ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2332325 AVELI CELLULITE RELEASE DEVICE OUP REVELLE AESTHETICS, INC. AVE001 22021702 OR 22030201 00850036790006

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Required Intervention