BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVELI

    MDR report key: 17836854 · Received September 28, 2023

    Report

    Report Number
    3020889437-2023-00009
    Event Type
    Injury
    Date Received
    September 28, 2023
    Date of Event
    September 12, 2023
    Report Date
    September 27, 2023
    Manufacturer
    REVELLE AESTHETICS, INC.
    Product Code
    OUP
    UDI-DI
    00850036790006
    PMA / PMN Number
    K221336
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT HAD A BBL PERFORMED BY ANOTHER PROVIDER APPROXIMATELY 6 MONTHS BEFORE THE AVÉLI PROCEDURE FOR CELLULITE. DURING THE PRE-AVÉLI CONSULT THE PHYSICIAN PALPATED AND FELT MORE THAN A DOZEN FIRM AREAS THAT HE DESCRIBED AS "OIL CYSTS" OR "FAT NECROSIS" FROM THE PREVIOUS BBL PROCEDURE, PRIMARILY IN THE INFERIOR BUTTOCKS. THE AVÉLI PROCEDURE WAS PERFORMED AS NORMAL, BUT DURING THE EXPRESSION OF THE ANESTHESIA FLUID AT THE END OF THE CASE, THE PHYSICIAN OBSERVED OIL FROM THE ENTRY SITE CONSISTENT WITH DRAINING AN OIL CYST. THE ONE-WEEK POST-AVÉLI FOLLOW UP WAS NORMAL WITH NO SEROMA OBSERVED. AT APPROXIMATELY 5 WEEKS FOLLOW UP THE PHYSICIAN ASPIRATED APPROXIMATELY 140CC OF SEROUS FLUID FROM THE INFERIOR RIGHT BUTTOCKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2246395 AVELI AVELI OUP REVELLE AESTHETICS, INC. NC82223A 00850036790006

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female Required Intervention