BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVELI

    MDR report key: 15395211 · Received September 9, 2022

    Report

    Report Number
    3020889-2022-00005
    Event Type
    Injury
    Date Received
    September 9, 2022
    Date of Event
    July 8, 2022
    Report Date
    September 9, 2022
    Manufacturer
    REVELLE AESTHETICS, INC.
    Product Code
    OUP
    UDI-DI
    00850036790006
    PMA / PMN Number
    K221336
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PATIENT PRESENTED WITH DEPRESSIONS OF MEDIUM AVERAGE DEPTH AND MODERATE LAXITY. PATIENT HAD FLANK AND LATERAL THIGH LIPOSUCTION ONE YEAR PRIOR. SEVEN DEPRESSIONS WERE TREATED: ONE LEFT POSTERIOR THIGH; ONE LEFT LATERAL THIGH; ONE RIGHT BUTTOCK; FOUR RIGHT LATERAL THIGH. IT WAS REPORTED THAT THE PATIENT DEVELOPED A SEROMA ON THE RIGHT LATERAL THIGH AFTER HER PROCEDURE. THE PHYSICIAN DRAINED THE SEROMA 4 TIMES. THE TOTAL VOLUME DRAINED WAS 25CC 1ST TIME, 10CC 2ND TIME, 10CC 3RD TIME, 5CC FINAL TIME. AT APPROXIMATELY ONE MONTH POST PROCEDURE, THE PATIENT REPORTED SHE'S PLEASED WITH HER OUTCOME AND THE SEROMA WASN'T A BOTHER AT ALL. SHE DID FOLLOW POST OP PROTOCOL AND WORE COMPRESSION PANTS 1 WEEK POST OP. AT TWO MONTHS POST PROCEDURE THE PATIENT IS DOING WELL. THERE IS NO PAIN OR DISCOMFORT BUT THERE IS STILL SOME DISCOLORATION/BRUISING AND HARDNESS IN THE AREA. THE PATIENT INDICATED THAT THE AREA LOOKS AND FEELS GOOD BUT SOME DIMPLES REMAIN VISUALLY IN PHOTOS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1806659 AVELI AVELI OUP REVELLE AESTHETICS, INC. AVE001 22061701 00850036790006

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Required Intervention