BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVELI

    MDR report key: 16694521 · Received April 6, 2023

    Report

    Report Number
    3020889437-2023-00003
    Event Type
    Injury
    Date Received
    April 6, 2023
    Date of Event
    March 14, 2023
    Report Date
    April 4, 2023
    Manufacturer
    REVELLE AESTHETICS, INC.
    Product Code
    OUP
    UDI-DI
    00850036790006
    PMA / PMN Number
    K221336
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    117

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH AVELI ON (B)(6) 2023. THE PATIENT WAS SEEN ONE MONTH LATER FOR FOLLOW UP. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN AREA THAT WAS WARM TO THE TOUCH AND A SEROMA/HEMATOMA WAS SUSPECTED. THE HCP ASPIRATED THE AREA AND REMOVED 54 CC'S OF BLOOD. THE PATIENT WAS PRESCRIBED ANTIBIOTICS. IT WAS REPORTED THAT THE AREA HAD IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2020134 AVELI AVELI OUP REVELLE AESTHETICS, INC. 22071301 OR 23012701 00850036790006

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Required Intervention