BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENUVION

    MDR report key: 12497132 · Received September 20, 2021

    Report

    Report Number
    3007593903-2012-00015
    Event Type
    Injury
    Date Received
    September 20, 2021
    Date of Event
    March 17, 2021
    Report Date
    September 17, 2021
    Manufacturer
    APYX MEDICAL CORPORATION
    Product Code
    GEI
    UDI-DI
    00607151050160
    PMA / PMN Number
    K191542
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    A LETTER WAS RECEIVED FROM A PATIENT WHO UNDERWENT A SUBDERMAL COAGULATION PROCEDURE OF THE BILATERAL INNER, ANTERIOR, OUTER AND POSTERIOR THIGHS AND QWO TO BILATERAL BUTTOCKS ON (B)(6) 2021. POST PROCEDURE, THE PATIENT NOTICED HER LIP WAS SWOLLEN (DUE TO ENDOTRACHEAL TUBE). THREE DAYS POST PROCEDURE, THE PATIENT COMPLAINED OF GAS IN HER CHEST AND NUMBNESS AND CONTINUED SWELLING TO HER LIP WHICH PERSISTED FOR TWO WEEKS. AT THIS TIME THE PATIENT NOTED SHE RETURNED FOR SUTURE REMOVAL AND HAD NOT SEEN ANY IMPROVEMENT TO HER THIGHS YET VISIBLE SIGNS OF "LARGER DIMPLES AND INDENTATIONS" AND WAVES TO HER THIGHS THAT WERE NOT PRE-EXISTING. THE PATIENT ALSO NOTED THAT SHE HAD INFECTIONS AND OPEN SORES TO BOTH INCISION POINTS ON EACH THIGH, SUTURES WERE LEFT IN PLACE AND HER THIGHS WERE BRUISED. ADDITIONALLY, SHE NOTES SHE HAD DARK SPOTS ON HER LEFT BUTTOCK WHERE THE QWO WAS INJECTED. THE PATIENT IS NOW SIX MONTHS POST PROCEDURE AND IS CLAIMING SHE HAS NOT SEEN ANY IMPROVEMENTS IN HER OUTCOME. ON (B)(6) 2021, THIS PATIENT CONSULTED WITH A DIFFERENT A PLASTIC SURGEON WHO NOTED THAT SHE HAS PATCHY DISCOLORATION AND HYPERPIGMENTATION TO AREAS OF HER ANTERIOR-MEDIAL THIGHS POTENTIALLY DUE TO A DECREASED BLOOD SUPPLY OF THE SKIN AFTER JPLASMA PROCEDURE. THE DOCTOR DISCUSSED NOT DOING TREATMENT AND AWAITING RESOLUTION VS SEEING A COSMETIC DERMATOLOGIST FOR LASER TREATMENT OF THE AREA IN ATTEMPT TO RESOLVE THE DISCOLORATION. THE PATIENT THEN CONSULTED WITH A DERMATOLOGIST WHO NOTED THAT THE PATIENT HAS DEVELOPED POST INFLAMMATORY HYPERPIGMENTATION FROM THE JPLASMA TIGHTENING. BASED ON ALL PROVIDED INFORMATION, THERE WAS NO REPORTED MALFUNCTION OF THE APYX DEVICE. HOWEVER, THE HYPERPIGMENTATION OF THE PATIENT'S THIGHS IS POTENTIALLY RELATED TO ELEVATED ENERGY LEVELS OF GAS CONCEIVABLY DECREASING BLOOD FLOW TO THE TREATED AREAS DURING THE SUBDERMAL COAGULATION PROCEDURE. ADDITIONALLY, A PHYSICIAN WHO IS AN INVESTIGATOR STUDYING CELLULITE, NOTED THAT THERE WAS A VERY HIGH AMOUNT OF ENERGY USED IN THIS TREATMENT. THE AMOUNT OF ENERGY USED PER THE OPERATIVE NOTE WAS 75% ENERGY AND 1.5LITER OF FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1395914 RENUVION RENUVION GEI APYX MEDICAL CORPORATION APYX-27-TP 00607151050160

    Patients

    Seq Age Sex Outcome Treatment
    1 Other