BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENUVION® APR HANDPIECE

    MDR report key: 19920015 · Received August 6, 2024

    Report

    Report Number
    3007593903-2024-00007
    Event Type
    Injury
    Date Received
    August 6, 2024
    Date of Event
    June 6, 2024
    Report Date
    August 6, 2024
    Manufacturer
    APYX MEDICAL CORPORATION
    Product Code
    GEI
    UDI-DI
    00607151050153
    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 MICROAIRE POWER ASSISTED LIPOSUCTION (PAL) FOLLOWED BY RENUVION TREATMENT IN THE NECK AND SUBMENTAL AREA. THE RENUVION DEVICE SETTINGS WERE 80% POWER WITH A 1.5 LPM HELIUM FLOW RATE AND A TOTAL OF 6.0 KILOJOULES (KJ) DELIVERED. THE DOCTOR STATES HE USED 3 SLOW SPEED RETROGRADE PASSES AT AN INTERMEDIATE PLANE DEPTH WITH TREATMENT STROKES PERFORMED AT 0.5 CM APART FROM EACH OTHER. A SIZE 2 MEDICAL Z COMPRESSION GARMENT WAS APPLIED POST PROCEDURE. TWO WEEKS POST-OPERATIVELY THE PATIENT CAME TO THE OFFICE FOR SUTURE REMOVAL AND PRESENTED WITH THE BURN. THE PATIENT WAS TREATED WITH HYPERBARIC OXYGEN, ANTIBIOTIC OINTMENTS, AND EXOSOMES FOR THE WOUND. APYX MEDICAL'S SUBDERMAL COAGULATION TECHNIQUE CONSIDERATIONS (SCTC) RECOMMENDS TREATMENT STROKES BE PERFORMED 2 - 3 CM APART. PERFORMING THE TREATMENT STROKES CLOSER TOGETHER THAN RECOMMENDED MAY HAVE CONTRIBUTED TO THE INJURY. 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 PRESENTED WITH A BURN ON THEIR NECK / CHIN / SUBMENTAL AREA 2 WEEKS AFTER A PROCEDURE IN WHICH RENUVION WAS USED AS PART OF THE OVERALL SURGICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1546567 RENUVION® APR HANDPIECE ELECTROSURGICAL HANDPIECE GEI APYX MEDICAL CORPORATION APYX-15-TP 0000024311 00607151050153

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Other MICROAIRE POWER ASSISTED LIPOSUCTION (PAL)