BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENUVION

    MDR report key: 13545465 · Received February 16, 2022

    Report

    Report Number
    3007593903-2022-00006
    Event Type
    Injury
    Date Received
    February 16, 2022
    Date of Event
    January 11, 2022
    Report Date
    February 11, 2022
    Manufacturer
    APYX MEDICAL CORPORATION
    Product Code
    GEI
    UDI-DI
    00607151050153
    PMA / PMN Number
    K191542
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE SURGEON THAT A (B)(6) YEAR OLD FEMALE PATIENT PRESENTED WITH UNILATERAL MARGINAL MANDIBULAR NERVE INJURY, TWO WEEKS POST LIPOSUCTION AND RENUVION TREATMENT TO THE SUBMENTAL AREA. UNDERMINED WAS PERFORMED IN THE SUBCUTANEOUS PLANE OF THE NECK THROUGH A SUBMENTAL CREASE SMALL INCISION WITH A 3.7MM SINGLE HOLE CANNULA. ABOUT 400 CC OF WETTING SOLUTION WAS INSTILLED AND A TOTAL OF 6 PASSES WERE PERFORMED. POST PROCEDURE, THE PATIENT WAS PLACED IN A COMPRESSION NECK WRAP. THE SURGEON'S MAIN CONCERN WAS TO BE REASSURED THIS WOULD NOT BE PERMANENT. THIS WAS THE SURGEON'S FIRST USE WITH RENUVION. THE PATIENT WILL CONSULT WITH A PLASTIC SURGEON FOR A POSSIBLE INJECTION OF A TOXIN TO THE UNAFFECTED SIDE FOR SYMMETRY UNTIL THE NERVE INJURY IMPROVES. CURRENTLY, THE PATIENT WAS PRESCRIBED AN ORAL STEROID IN EFFORT TO SPEED THE HEALING TIME OF THE NERVE INJURY. ADDITIONAL INFORMATION WAS RECEIVED ON 2/14/2022 PROVIDING THE DEVICE INFORMATION, APYX-15-TP, LOT#0000013937. THE SURGEON USED A 3.7 MM SINGLE HOLE CANNULA FOR UNDERMINING, INFILTRATED WITH 400CC OF FLUID. THE LOCATION OF INSERTION SITES WERE AT THE SUBCUTANEOUS PLANE OF THE NECK, THROUGH A SUBMENTAL CREASE INCISION. SIX PASSES AT 60% GAS AND 1.5 LITERS OF FLOW OF HELIUM AND A TOTAL OF 6.3KJ. NECK COMPRESSION GARMENT WAS APPLIED POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2234508 RENUVION RENUVION GEI APYX MEDICAL CORPORATION APYX-15-TP 00607151050153

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female Other