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 10/18/2021

Event Type  Injury  

Event Description

It was reported that a patient sustained bruising, blisters, and skin color changes after the use of renuvion.This is patient underwent a liposuction and renuvion treatment to the flanks, upper and back on (b)(6) 2021.This is a (b)(6) year old patient with a medical history of liposuction and mastopexy in 2019 and she is a smoker.The generator settings were noted at 70% gas and 2.0 flow and 3l infiltration.The insertion sites were at the supra pubic, inner part of umbilical area 12 o clock, axillar area (linea axillar posterior).Tumescent anesthesia was used with nacl and tranexamic acid with 1 ampule of adrenaline.There was no liposuction to the abdomen, the back area and flanks had the renuvion treatment and 4 passes were performed.The complication are in abdominal area at the oblique area with 2 x 3 cm blisters, silvaderma and hyperbaric oxygen treatment was provided.The patient has progressed satisfactorily.The surgeon believes the apyx medical device caused and/or contributed to this event.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
• Manufacturer Contact: aylin canlar ; 5115 ulmerton road; clearwater, FL 33760-4004 ; 7273842323
• MDR Report Key: 12756022
• MDR Text Key: 280439856
• Report Number: 3007593903-2021-00024
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2021
• 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: 10/18/2021
• 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: 38 YR
• Patient Sex: Female