BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVELI

    MDR report key: 16160032 · Received January 13, 2023

    Report

    Report Number
    3020889437-2023-00001
    Event Type
    Injury
    Date Received
    January 13, 2023
    Date of Event
    December 21, 2022
    Report Date
    January 13, 2023
    Manufacturer
    REVELLE AESTHETICS, INC.
    Product Code
    OUP
    UDI-DI
    00850036790006
    PMA / PMN Number
    K221336
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PATIENT PRESENTED WITH DEPRESSIONS OF MEDIUM AVERAGE DEPTH AND MILD LAXITY. TEN DEPRESSIONS WERE TREATED: 6 ON THE LEFT BUTTOCK AND 4 ON THE RIGHT BUTTOCK. IT WAS REPORTED THAT AT TWO WEEKS POST PROCEDURE SMALL POCKETS OF SWELLING WERE OBSERVED IN THE TREATMENT AREA. PATIENT WAS WEARING COMPRESSION GARMENTS AND WAS ADVISED TO MASSAGE 3 TIMES DAILY. THE PHYSICIAN REPORTED THAT THEY EXAMINED THE PATIENT AND DIAGNOSED SEROMAS ON THE LEFT AND RIGHT BUTTOCKS. THE PHYSICIAN DRAINED 15-20 CC FROM EACH OF THE TWO SEROMAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1963696 AVELI AVELI OUP REVELLE AESTHETICS, INC. 22092203 OR 22081901 00850036790006

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Required Intervention