BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENUVION

    MDR report key: 24475266 · Received February 27, 2026

    Report

    Report Number
    3007593903-2026-00001
    Event Type
    Injury
    Date Received
    February 27, 2026
    Date of Event
    December 2, 2025
    Report Date
    March 17, 2026
    Manufacturer
    APYX MEDICAL CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K230272
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE TREATMENT PLAN INCLUDED LIPOSUCTION TO THE NECK AND CHIN FOLLOWED BY RENUVION TREATMENT TO THE CHIN. THE PATIENT WAS INFILTRATED WITH 250 ML OF TUMESCENCE SOLUTION. 200ML OF FAT WAS ASPIRATED USING A 3MM MECEDES CANNULA DURING THE LIPOSUCTION PORTION OF THE PROCEDURE. THE RENUVION DEVICE SETTINGS WERE 80% POWER AND 1.5LPM OF HELIUM FLOW. SIX SUPERFICIAL PASSES WERE COMPLETED 1 INCH APART, AT A 2CM/SEC TREATMENT SPEED, DELIVERING APPROXIMATELY 8KJ OF RENUVION ENERGY TO THE PATIENT. AT THE ONE-WEEK POST-OPERATIVE VISIT, THE PATIENT'S CHIN WAS OBSERVED BY THE DOCTOR AS LOOKING "GREAT". THE PATIENT HAD MINIMAL BRUISING AND EDEMA AND WAS PLACED IN A COMPRESSION GARMENT. THREE DAYS AFTER THE ONE-WEEK POST-OPERATIVE APPOINTMENT THE PATIENT FELT A "POP" IN THEIR NECK WHEN STANDING UP FROM A CHAIR. THEY EXPERIENCED IMMEDIATE INCREASED SWELLING IN THEIR NECK AND WERE ADMITTED TO AN EMERGENCY ROOM. THE PATIENT WAS INTUBATED TO PROTECT HER AIRWAY FROM ANY CONTINUED SWELLING. SHE WAS THEN TRANSFERRED TO ANOTHER FACILITY WHERE SHE UNDERWENT DRAINAGE OF THE HEMATOMA. AFTER DISCHARGE FROM THE HOSPITAL, THE PATIENT WAS READMITTED WITH AN INFECTION AT THE DRAINAGE SITE. HEMATOMA IS A KNOWN POTENTIAL COMPLICATION OF LIPOSUCTION PROCEDURES. IT IS NOT UNCOMMON FOR PRESENTATION TO OCCUR 3-7 DAYS POST-PROCEDURE AND OCCASIONALLY EVEN LATER. DELAYED HEMATOMAS CAN OCCUR FOR MULTIPLE REASONS INCLUDING BUT NOT LIMITED TO INCREASED ACTIVITY TOO SOON, INADEQUATE COMPRESSION GARMENT USE, USING ANTICOAGULANTS AND/OR SUPPLEMENTS, OR FROM A SPIKE IN BLOOD PRESSURE SUCH THAT MAY OCCUR FROM STANDING FROM A SEATED POSITION. HEMATOMA IS ALSO A KNOWN RISK ASSOCIATED WITH THE USE OF RENUVION. RENUVION RISKS INCLUDED IN THE INSTRUCTIONS FOR USE ARE: UNINTENDED BURNS (DEEP OR SUPERFICIAL), PAIN, DISCOMFORT, BLEEDING, HEMATOMA, SEROMA, INCREASED HEALING TIME, UNSATISFACTORY SCARRING, ASYMMETRY AND/OR UNACCEPTABLE COSMETIC RESULT.

    Description of Event or Problem · 0

    THE PATIENT DEVELOPED RAPID SWELLING OF THE NECK WHEN SHE FELT A "POP" IN HER NECK 10 DAYS 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
    530420 RENUVION ELECTROSURGICAL HANDPIECE GEI APYX MEDICAL CORPORATION APYX-15-TP

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other LIPOSUCTION - PRODUCT AND TYPE NOT IDENTIFIED.