MAUDE Adverse Event Report: APYX MEDICAL CORPORATION RENUVION

Model Number	APYX-27-TP
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Skin Discoloration (2074)
Date of Event	03/17/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A letter was received from a patient who underwent a subdermal coagulation procedure of the bilateral inner, anterior, outer and posterior thighs and qwo to bilateral buttocks on (b)(6) 2021.Post procedure, the patient noticed her lip was swollen (due to endotracheal tube).Three days post procedure, the patient complained of gas in her chest and numbness and continued swelling to her lip which persisted for two weeks.At this time the patient noted she returned for suture removal and had not seen any improvement to her thighs yet visible signs of "larger dimples and indentations" and waves to her thighs that were not pre-existing.The patient also noted that she had infections and open sores to both incision points on each thigh, sutures were left in place and her thighs were bruised.Additionally, she notes she had dark spots on her left buttock where the qwo was injected.The patient is now six months post procedure and is claiming she has not seen any improvements in her outcome.On (b)(6) 2021, this patient consulted with a different a plastic surgeon who noted that she has patchy discoloration and hyperpigmentation to areas of her anterior-medial thighs potentially due to a decreased blood supply of the skin after jplasma procedure.The doctor discussed not doing treatment and awaiting resolution vs seeing a cosmetic dermatologist for laser treatment of the area in attempt to resolve the discoloration.The patient then consulted with a dermatologist who noted that the patient has developed post inflammatory hyperpigmentation from the jplasma tightening.Based on all provided information, there was no reported malfunction of the apyx device.However, the hyperpigmentation of the patient's thighs is potentially related to elevated energy levels of gas conceivably decreasing blood flow to the treated areas during the subdermal coagulation procedure.Additionally, a physician who is an investigator studying cellulite, noted that there was a very high amount of energy used in this treatment.The amount of energy used per the operative note was 75% energy and 1.5liter of flow.

• Brand Name: RENUVION
• Common Device Name: RENUVION
• Manufacturer (Section D): APYX MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760 4004
• MDR Report Key: 12497132
• Report Number: 3007593903-2012-00015
• Device Sequence Number: 11709324
• Product Code: GEI
• UDI-Device Identifier: 00607151050160
• UDI-Public: 00607151050160
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191542
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2021

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
• Operator of Device: Health Professional
• Device Model Number: APYX-27-TP
• Device Catalogue Number: APYX-27-TP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 09/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other