MAUDE Adverse Event Report: APYX MEDICAL CORPORATION RENUVION

Model Number APYX-270BPP

Device Problems Use of Device Problem (1670); Patient Device Interaction Problem (4001)

Patient Problems Burn(s) (1757); Scar Tissue (2060)

Event Date 06/19/2021

Event Type  Injury  

Event Description

It was reported on (b)(6) 2021 that a patient underwent a combination procedure of vaser liposuction, inmode bodytite, and renuvion and sustained a burns to the abdomen.The patient only consented for liposuction to be performed during the procedure.The inmode and renuvion products were used without her prior consent.The vaser setting was 80% and the renuvion setting was 100% power which is outside of the recommended use setting.No information was available on the inmode setting used.However, bodytite was used twice during the procedure.The surgeon was untrained on the use of the renuvion product.Apyx medical became aware of the incident, because the patient is a plastic surgeon who is a user of the renuvion technology who mentioned the event to her sales representative.The procedure was done in her office, where the renuvion is located.The providing physician was told not to use the system.The burn was caused by the delivery of too much energy to the abdominal tissue through the use of multiple energy devices during the procedure.The investigation is inconclusive regarding which of the three energy sources caused the burn.

• Brand Name: RENUVION
• Type of Device: RENUVION
• Manufacturer (Section D): APYX MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760 4004
• Manufacturer (Section G): 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: 13959211
• MDR Text Key: 288289250
• Report Number: 3007593903-2022-00010
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607151050061
• UDI-Public: 00607151050061
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151325
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: APYX-270BPP
• Device Catalogue Number: APYX-270-BPP
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/28/2022
• Initial Date FDA Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: VASER LIPOSUCTION AND INMODE BODYTITE
• Patient Outcome(s): Other
• Patient Sex: Female