MAUDE Adverse Event Report: APYX MEDICAL CORPORATION RENUVION

Device Problems Device Handling Problem (3265); Patient Device Interaction Problem (4001)

Patient Problems Bruise/Contusion (1754); Burn(s) (1757); Full thickness (Third Degree) Burn (2696)

Event Date 09/22/2021

Event Type  Injury  

Event Description

It was reported that a patient underwent a tummy tuck, vaser liposuction and renuvion treatment to the flanks, upper dorsal area, arms and between the legs and hips on (b)(6) 2021.However, the surgeon's patients are having a different recovery process (bruises and blisters and change in skin color).This is patient one of five with a different recovery process.It was noted that the handpiece was disconnected and connected a few times, yet continued to have f errors.A new handpiece was used with no problem.On 10/19/2021, additional information was provided; this is a (b)(6) female patient with a medical history of 2 births and a surgical history of tummy tuck, liposuction and mastopexy 5 years ago.The catalog information used during this procedure is not available.The generator settings were 60% gas and 2.0 liters of flow.The insertion sites for the procedure were at the supra pubic area, infiltration was done with the vaser infiltration system, tumescent anesthesia was used.At the legs and arms 4 passes were performed and at the back, 4 passes were performed.Subsequently, due to the reported bruises and change in skin color, the patient was treated at the supra gluteal sulcus, 1/3 medial part of the right arm and the 1/3 proximal internal part of the right leg and the internal part of the right leg which also required debriding to the inner part of the leg.This patient is being treated with silvaderma once a week combined with hyperbaric chamber and aquacel.Currently, the patient is slowly improving.Based on the provided information and customer feedback form, there is no alleged malfunction of the device.However, due to the surgeon's technique, the patient suffered burns to the areas treated for subdermal coagulation.

• Brand Name: RENUVION
• Type of Device: RENUVION
• Manufacturer (Section D): APYX MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760 4004
• MDR Report Key: 12752608
• MDR Text Key: 280165504
• Report Number: 3007593903-2021-00022
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2021
• 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: 10/19/2021
• 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): Required Intervention
• Patient Age: 28 YR