MAUDE Adverse Event Report: APYX MEDICAL CORPORATION RENUVION

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Adhesion(s) (1695)

Event Date 10/06/2021

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2021, a female patient with a history of breast cancer (no chemotherapy or radiation) and previous abdominal surgery underwent liposuction to the lower abdomen followed by subdermal coagulation with renuvion.Three passes utilizing the antegrade-retrograde technique in the superficial and deep treatment planes were performed with generator settings of 80% gas and 2.0 liters of flow.1000cc of tumescent was administered to the patient.During the procedure, 800cc of fluid and fat were removed from the patient, abdominal etching was performed and 800 cc of aspiration was performed.A foam compression garment was worn for 2 months post procedure.The patient did not have lymphatic drainage massage or any relevant techniques performed.Subsequently, the patient presented with abdominal adhesions to the treated area.The surgeon initially planned to have massages performed to the patient in effort to correct the adhesion.However, if massages do not correct the adhesion, he is prepared to release the adhesion if there is no improvement.A peer to peer consultation was held between the surgeon and a member of the apyx medical advisory board.It was noted that this surgeon is relatively "young" in his liposuction career.Techniques and technologies were discussed as well as tumescent anesthesia mixes, settings and endpoints for surgical body contouring and energy treatments.Additionally, major recommendations for best outcomes including possible ways to enhance the cases of tissue adhesions the performing surgeon currently practices was discussed.Guidance on how to treat the adhesions were also provided to the performing surgeon.

• 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: 13238050
• MDR Text Key: 284907483
• Report Number: 3007593903-2022-00002
• 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
• Type of Report: Initial
• Report Date: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• 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: 12/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other
• Patient Sex: Female