BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENUVION

    MDR report key: 15476014 · Received September 24, 2022

    Report

    Report Number
    3007593903-2022-00017
    Event Type
    Injury
    Date Received
    September 24, 2022
    Date of Event
    February 24, 2022
    Report Date
    September 19, 2022
    Manufacturer
    APYX MEDICAL CORPORATION
    Product Code
    GEI
    UDI-DI
    00607151050153
    PMA / PMN Number
    K191542
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT UNDERWENT VASER LIPOSUCTION FOLLOWED BY SUBDERMAL COAGULATION WITH RENUVION TO THE SUBMENTAL AREA. ONE PASS WITH RENUVION WAS PERFORMED AT GENERATOR SETTINGS OF 80% POWER AND 1.5 LITERS OF FLOW. SPEED, SPACING, INFILTRATION SOLUTION AND AMOUNT, TREATMENT PLANE DEPTHS, AND ASPIRATION AMOUNT WAS REQUESTED BUT NOTED AS UNKNOWN BY THE SURGEON'S OFFICE. PATIENT WORE A GARMENT POST PROCEDURE AND FOLLOWED AFTER CARE INSTRUCTIONS PER HER SURGEON'S PROTOCOL. HOWEVER, THREE DAYS POST PROCEDURE, A BURN TO THE TREATED AREA WAS NOTICED. THE DEGREE OF BURN WAS NOT CONFIRMED BY THE SURGEON. MULTIPLE STEROID INJECTIONS OF KENALOG WERE ADMINISTERED BY THE SURGEON TO THE AFFECTED AREA ON (B)(6) 2022. ADDITIONALLY, MICRO-NEEDLING WAS PERFORMED ON (B)(6) 2022 IN EFFORT TO TREAT THE BURN. ALTHOUGH THE SURGEON NOTED THAT THE PATIENT WAS HEALING, THE PATIENT HAS A VISIBLE SCAR POST PROCEDURE AND TREATMENTS AS A RESULT OF THE BURN. THE CAUSE OF THE BURN IS DUE TO END HITS. THE END HITS MAY HAVE BEEN CAUSED BY THE APYX MEDICAL DEVICE OR THE VASER DEVICE OR A COMBINATION OF BOTH DURING THE PROCEDURE. END HITS ARE NOT A RECOMMENDED TECHNIQUE PER THE APYX MEDICAL TECHNIQUE CONSIDERATIONS WHICH ARE DISCLOSED DURING CUSTOMER TRAINING. AS IT IS UNKNOWN IF THE END HITS WERE CAUSED OR CONTRIBUTED BY THE VASER DEVICE OR BY THE APYX MEDICAL DEVICE, THIS EVENT IS DEEMED REPORTABLE AS A USE ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1651769 RENUVION RENUVION GEI APYX MEDICAL CORPORATION APYX-15-TP 00607151050153

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| S VASER LIPOSUCTION