BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENUVION

    MDR report key: 19656499 · Received July 2, 2024

    Report

    Report Number
    3007593903-2024-00006
    Event Type
    Injury
    Date Received
    July 2, 2024
    Date of Event
    May 7, 2024
    Report Date
    July 1, 2024
    Manufacturer
    APYX MEDICAL CORPORATION
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT IS A 53 Y/O FEMALE WITH A HISTORY OF MS. IN ADDITION TO OTHER UNASSOCIATED PROCEDURES, THE PATIENT UNDERWENT LIPOSUCTION OF THE BILATERAL MEDIAL AND LATERAL THIGHS AND KNEES. LIPOSUCTION WAS CONDUCTED USING A BLACK AND BLACK POWER ASSISTED DEVICE. THE DOCTOR MADE 3 ANTERIOR / RETROGRADE (6 TOTAL) PASSES, DELIVERING 3.3 KILOJOULES (KJ) TO THE RIGHT LATERAL THIGH, AND 4.3 KJ TO THE RIGHT MEDIAL THIGH. AFTER THE PROCEDURE, THE PATIENT WAS PLACED IN A COMPRESSION GARMENT. AT THE FIRST FOLLOW-UP VISIT, A "DIME SIZED" INDURATION WAS NOTED. INITIALLY, IT WAS A DARK SPOT BUT LATER BEGAN TO SCAB AND WAS TREATED WITH BACITRACIN. PATIENT INJURY SUBSEQUENTLY PROGRESSED TO A THIRD DEGREE BURN.

    Description of Event or Problem · 0

    THE PATIENT SUSTAINED A THIRD DEGREE BURN ON THEIR RIGHT MEDIAL THIGH AFTER A LIPOSUCTION PROCEDURE IN WHICH RENUVION WAS USED AS PART OF THE OVERALL SURGICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685024 RENUVION ELECTROSURGICAL HANDPIECE GEI APYX MEDICAL CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Other BLACK AND BLACK POWER ASSISTED LIPOSUCTION DEVICE