BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVELI

    MDR report key: 17302337 · Received July 11, 2023

    Report

    Report Number
    3020889437-2023-00007
    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 WAS VERY BRUISED IN THE RIGHT OUTER THIGH POST-OP. AT FOLLOW UP THE PATIENT PRESENTED WITH A SEROMA. THE PHYSICIAN DRAINED 80CC OF OLD BLOOD FROM THE BRUISED AREA AT 1-WEEK POST-OP, AND PERFORMED SERIAL DRAINAGES SEVERAL TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1893566 AVELI AVELI OUP REVELLE AESTHETICS, INC. 23041401 00850036790006

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention