BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVELI

    MDR report key: 22879920 · Received August 22, 2025

    Report

    Report Number
    3020889437-2025-00004
    Event Type
    Injury
    Date Received
    August 22, 2025
    Date of Event
    August 4, 2025
    Report Date
    August 22, 2025
    Manufacturer
    REVELLE AESTHETICS, INC.
    Product Code
    OUP
    UDI-DI
    00850036790006
    PMA / PMN Number
    K232153
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN AVELI PATIENT PRESENTED AT ONE MONTH POST TREATMENT WITH RESIDUAL FLUID RETENTION AT THE TREATMENT AREA. THE PATIENT FOLLOWED INSTRUCTIONS FROM THE PROVIDER. THE PROVIDER EVALUATED THE FLUID RETENTION ON ULTRASOUND. THE PROVIDER REPORTED THAT THERE IS NO INDURATION AND/OR SIGNS OF INFECTION AT THE SITE, AND THAT THE PATIENT HAD A SIGNIFICANT AMOUNT OF CELLULITE. THE PROVIDER REPORTED THAT THEY DRAINED OUT ANY POST PROCEDURE FLUID AFTER THE TREATMENT. PATIENT WAS STARTED ON BROMALINE AND ARNICA. THE PROVIDER WAS ADVISED TO DRAIN THE SEROMAS AND INSTRUCT THE PATIENT TO WEAR COMPRESSION GARMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2018720 AVELI AVELI OUP REVELLE AESTHETICS, INC. ALL ACTIONS HAVE BEEN COMPLETE 00850036790006

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Required Intervention