BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENUVION APR HANDPIECE

    MDR report key: 19008336 · Received March 29, 2024

    Report

    Report Number
    3007593903-2024-00003
    Event Type
    Injury
    Date Received
    March 29, 2024
    Date of Event
    February 9, 2024
    Report Date
    March 29, 2024
    Manufacturer
    APYX MEDICAL CORPORATION
    Product Code
    GEI
    UDI-DI
    00607151050160
    PMA / PMN Number
    K230272
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT UNDERWENT LIPOSUCTION USING THE MICROAIRE POWER ASSISTED LIPOSUCTION (PAL) SYSTEM AND TUMESCENT LOCAL ANESTHESIA WITH APPROXIMATELY 400CC INFUSION IN EACH THIGH. 300CC OF FAT WAS ASPIRATED FOR EACH INNER THIGH WITH A 4MM CANNULA FOLLOWING TREATMENT WITH RENUVION. THE GENERATOR SETTINGS FOR THE APYX HANDPIECE WERE 60% POWER WITH A 1.5 LPM HELIUM FLOW RATE. THE DOCTOR DESCRIBES THE HANDPIECE PASSES AS STEADY AND SLOW AT AN INTERMEDIATE OR DEEPER PLANE DEPTH WITH AT LEAST 1 CM BETWEEN EACH PASS. AT THE CONCLUSION OF THE PROCEDURE, THE DOCTOR STATES THAT BOTH THIGHS WERE CHECKED AND THERE WAS NO HEAT GENERATED FROM THE PROCEDURE AFTER THE RENUVION TREATMENT WAS DONE. THE PATIENT WAS PLACED IN A COMPRESSION GARMENT POSTOPERATIVLY FOR 1 WEEK PRIOR TO BEING SEEN AGAIN BY THE DOCTOR. AT THE FOLLOW-UP VISIT THE PATIENT REPORTED TENDERNESS ON THEIR RIGHT INNER THIGH (APPROX. 5 X 8 CM). THE DOCTOR DETERMINED THIS TO BE A SECOND DEGREE BURN AND IT WAS DEBRIDED AT THE BEDSIDE. THE PATIENT WAS TREATED WITH LOCAL WOUND CARE INCLUDING SILVADENE CREAM AND WAS SEEN SEVERAL TIMES IN THE OFFICE FOR LOCAL WOUND CARE. THE BURN PROGRESSED TO A THIRD DEGREE BURN WHICH WAS TREATED WITH SURGICAL DEBRIDEMENT AND CONTINUED LOCAL WOUND CARE UNTIL THE WOUND APPEARED TO HAVE CLEAN GRANULATION TISSUE. THE PATIENT SUBSEQUENTLY UNDERWENT A FULL-THICKNESS SKIN GRAFT WHICH APPEARS TO BE HEALING. THE DEVICE WAS DISCARDED AND NOT AVAILABLE FOR EVALUATION. TEMPORARY AND/OR PERMANENT INJURY AS A RESULT OF A BURN IS A KNOWN POTENTIAL COMPLICATION FOR THIS TECHNOLOGY AND TREATMENT.

    Description of Event or Problem · 0

    THE PATIENT SUSTAINED A DEEP PARTIAL-THICKNESS (SECOND-DEGREE) BURN WHICH PROGRESSED INTO A FULL-THICKNESS (THIRD-DEGREE) BURN ON THEIR RIGHT INNER THIGH AFTER MICROAIRE POWER ASSISTED LIPOSUCTION (PAL) WAS PERFORMED AND IN WHICH RENUVION WAS USED AS PART OF THE OVERALL SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2593125 RENUVION APR HANDPIECE ELECTROSURGICAL HANDPIECE GEI APYX MEDICAL CORPORATION APYX-27-TP 00607151050160

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| O MICROAIRE POWER ASSISTED LIPOSUCTION (PAL)