BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVELI

    MDR report key: 14854377 · Received June 29, 2022

    Report

    Report Number
    3020889437-2022-00001
    Event Type
    Injury
    Date Received
    June 29, 2022
    Date of Event
    May 27, 2022
    Report Date
    June 24, 2022
    Manufacturer
    REVELLE AESTHETICS, INC.
    Product Code
    OUP
    UDI-DI
    00850036790006
    PMA / PMN Number
    K212399
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORT WAS DELAYED DUE TO THE ELECTRONIC SIGNUP PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED A SEROMA IN THE BUTTOCKS, OBSERVED BY THE TREATING PHYSICIAN DURING THE TWO-WEEK FOLLOW-UP APPOINTMENT AFTER THE PROCEDURE. THE PATIENT PRESENTED WITH MEDIUM DEPRESSION DEPTH, MODERATE LAXITY, FITZPATRICK SKIN TYPE V. 22 DEPRESSIONS WERE TREATED: 5 LEFT BUTTOCK, 3 LATERAL THIGH, 13 RIGHT BUTTOCK, 1 RIGHT LATERAL THIGH. PATIENT HAD A GLUTEAL AUGMENTATION AND LIPOSUCTION 1 YEAR PRIOR. ONE SEROMA WAS PRESENT ON THE RIGHT BUTTOCK LOCATED LATERAL AND SUPERIOR TO GLUTEAL CREASE ENTRY POINT. THE SIZE OF THE SEROMA WAS ROUGHLY 1"X1". THE TOTAL VOLUME DRAINED VIA NEEDLE WAS APPROXIMATELY 25ML. ONE SEROMA WAS OBSERVED ON THE LEFT BUTTOCK MEDIAL AND SUPERIOR TO GLUTEAL CREASE ENTRY POINT. THE SIZE OF THE SEROMA WAS ROUGHLY 1"X2" AND THE TOTAL VOLUME DRAINED VIA NEEDLE WAS APPROXIMATELY 30ML. THE PATIENT WAS ADVISED TO WEAR A MEDICAL GRADE COMPRESSION GARMENT FOR 1 WEEK. AFTER ONE WEEK, THE PHYSICIAN ASPIRATED THE SEROMAS WITH ½ THE VOLUME AS THE WEEK PRIOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1090610 AVELI CELLULITE RELEASE DEVICE OUP REVELLE AESTHETICS, INC. AVE001 22021702 00850036790006

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Female Required Intervention