MAUDE Adverse Event Report: APYX MEDICAL CORPORATION RENUVION

Device Problems Improper or Incorrect Procedure or Method (2017); Patient Device Interaction Problem (4001)

Patient Problems Burn(s) (1757); Laceration(s) (1946); Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)

Event Date 01/21/2022

Event Type  Injury  

Event Description

It was reported that 24 hours post liposuction followed by subdermal coagulation (except on saddle bags), the patient presented with second and third degree burns to the front thigh and abdomen.This patient is a (b)(6) female with a medical history of 2 pregnancies, 2 caesarean sections and is a health fitness.It was noted that the largest burn was 10 cm x 4 cm.The generator was used in front thigh (70% power, 2 l/min and 6 passes) and abdomen (80% power, 2 l/min and 6 passes).Compression was applied after surgery.The treatment planes were intermediate and deep.The current treatment plan to treat the patient burns are hyperbaric treatment, broad spectrum oral antibiotic, trental (anti-inflammatory and vasodilator to treat poor blood circulation by improving the flow of blood) 400 mg twice a day and several ointments to keep the burns moist.It was also noted that the surgeon had no training nor clinical in-service and this was his second case using renuvion.The surgeon believes that because of a bad connection of the handpiece to the generator or, because a failure of the handpiece, the plasma produced was not adequate and produced the lesions.Orange plasma from the handpiece was the only unique factor in this case, per the surgeon.However, all other parameters and protocols were followed.

• Brand Name: RENUVION
• Type of Device: RENUVION
• Manufacturer (Section D): APYX MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760 4004
• Manufacturer Contact: aylin canlar ; 5115 ulmerton road; clearwater, FL 33760-4004 ; 7273842323
• MDR Report Key: 13444688
• MDR Text Key: 285003022
• Report Number: 3007593903-2022-00005
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female