BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVELI

    MDR report key: 20112568 · Received August 30, 2024

    Report

    Report Number
    3020889437-2024-00004
    Event Type
    Injury
    Date Received
    August 30, 2024
    Date of Event
    August 6, 2024
    Report Date
    August 29, 2024
    Manufacturer
    REVELLE AESTHETICS, INC.
    Product Code
    OUP
    PMA / PMN Number
    K232153
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN AVÉLI PATIENT HAD SIGNIFICANTLY MORE SWELLING/BRUISING ON HER LEFT SIDE COMPARED TO HER RIGHT SIDE IMMEDIATELY AFTER THE AVÉLI PROCEDURE. AT TWO WEEKS POST PROCEDURE THE PATIENT REPORTED ONGOING SWELLING AND BRUISING AND THAT HER THIGHS WERE VERY PAINFUL, HOT AND BURNING. THE PATIENT REPORTED A "LARGE DEFORMITY" ON HER LEFT THIGH. PATIENT REPORTED THAT HER RIGHT THIGH HAD AN AREA THAT WAS RED AND INFLAMED. THE SYMPTOMS WERE DIAGNOSED BY THE PHYSICIAN TO BE A LIKELY INFECTED SEROMA. PATIENT WAS ADVISED TO WEAR COMPRESSION GARMENTS AND WAS PRESCRIBED ANTIBIOTICS. IT WAS REPORTED THAT THE AREA RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1006020 AVELI AVELI OUP REVELLE AESTHETICS, INC. NC80524001

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Required Intervention