BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVELI

    MDR report key: 16236456 · Received January 24, 2023

    Report

    Report Number
    3020889437-2022-00009
    Event Type
    Injury
    Date Received
    January 24, 2023
    Date of Event
    August 1, 2022
    Report Date
    January 11, 2023
    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

    Additional Manufacturer Narrative · 0

    THE REPORT WAS ORIGINALLY SENT ON 11/3/2022, BUT WITH AN INCORRECT REPORT NUMBER; SO THIS REPORT IS A RESUBMISSION. THE ORIGINAL REPORT NUMBER WAS 3020889-2022-00009 INSTEAD OF 3020889437-2022-00009.

    Description of Event or Problem · 0

    IT WAS PREVIOUSLY REPORTED THAT A FEMALE PATIENT DEVELOPED A WOUND REQUIRING DEBRIDEMENT FOLLOWING A TUMMY TUCK, LIPO 360, AND AVÉLI PROCEDURES. FAT NECROSIS WAS FOUND IN THE AREA UNDERNEATH THE WOUND, AND THE PATIENT WOULD LIKELY NEED A SURGERY TO ADDRESS THE VOLUME LOSS. THE TREATING PHYSICIAN REPORTED THAT THE WOUND WAS NEAR THE BONEY PROMINENCE OF THE ISCHIUM AND IS CONSISTENT WITH A PRESSURE WOUND. THE PATIENT RETURNED FOR FOLLOW UP TWO MONTHS AFTER THE WOUND DEBRIDEMENT AND IT WAS REPORTED THAT THE WOUND BED IS HEALING WELL. ON (B)(6) 2023, THE TREATING PHYSICIAN PROVIDED AN UPDATE REGARDING THE PATIENT. IT WAS REPORTED THAT THE PATIENT'S FAT NECROSIS ON THE LEFT BUTTOCK IS HEALING WELL. THE OPENING IN THE SKIN IS SMALLER AND IS NOW SEVERAL MILLIMETERS WIDE. IT WAS REPORTED THAT THE PATIENT STILL HAS SOME AREAS OF FIRMNESS ON THE RIGHT BUTTOCKS AND IS RETURNING TO THE OFFICE TWICE PER WEEK FOR MASSAGE TO BREAK UP THE AREAS OF FIRMNESS. FOR FUTURE COSMETIC IMPROVEMENT, THE PHYSICIAN IS PLANNING 2-3 TREATMENTS WITH SCULPTRA® OVER SEVERAL MONTHS ON BOTH THE LEFT AND RIGHT BUTTOCKS TO FILL THE VOLUME DEFICIENCY AFTER THE FAT NECROSIS ON THE LEFT SIDE AND TO SOFTEN THE RIGHT SIDE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FEMALE PATIENT HAD A TUMMY TUCK, LIPO 360, AND AVÉLI PROCEDURES ON (B)(6) 2022. AT ABOUT 4-6 WEEKS POST PROCEDURE, THE PATIENT CAME IN FOR FOLLOW-UP AND THERE WAS A SMALL DARK BLACK SCAB ON THE LATERAL LEFT BUTTOCK. THE SMALL BLACK ESCHAR WAS INDURATED BUT NOT INFECTED AT 6 WEEKS. THE TREATING PHYSICIAN ADVISED THE PATIENT TO TAKE PRESSURE OFF THE AREA AND IT WAS REPORTED THAT THEY EXPECTED THE WOUND TO HEAL. ABOUT 3 MONTHS POST AVÉLI PROCEDURE, THE PATIENT RETURNED FOR FOLLOW-UP AND AT THIS POINT THE OR NURSE AND TREATING PHYSICIAN REPORTED THE AREA OF CONCERN AS "GROSSLY INFECTED, AN ABSCESS." IT WAS REPORTED THAT THE WOUND REQUIRED DEBRIDEMENT, FAT NECROSIS WAS FOUND IN THE AREA UNDERNEATH THE WOUND, AND THE PATIENT WOULD LIKELY NEED A SURGERY TO ADDRESS THE VOLUME LOSS. THE TREATING PHYSICIAN REPORTED THAT THE WOUND WAS NEAR THE BONEY PROMINENCE OF THE ISCHIUM AND IS CONSISTENT WITH A PRESSURE WOUND. THE PATIENT RETURNED FOR FOLLOW UP TWO MONTHS AFTER THE WOUND DEBRIDEMENT AND IT WAS REPORTED THAT THE WOUND BED IS HEALING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1034375 AVELI AVELI OUP REVELLE AESTHETICS, INC. 22011803 00850036790006

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Required Intervention