MAUDE Adverse Event Report: APYX MEDICAL CORPORATION RENUVION

Model Number	APYX-27-TP
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	11/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no malfunction observed during the procedure.However, the doctor did state he believes renuvion may have caused or contributed to the patient's burns.The doctor and the apyx medical vice president of medical affairs discussed several potential ways these burns could have happened: the patient was 66 years old with thin skin.The power setting of 85% may have been too high.60%-80% is the recommended settings and with thin skin and her age using 60% would have been more appropriate.The doctor admitted he has used tenting the tissue in his technique.There was also discussion that the patient was thin, and the doctor only treated in one surgical plane; this may have left him treating too superficial.If more information becomes available, a supplemental report will be filed as appropriate.
Event or Problem Description
An apyx medical sales representative reported on 01dec2022 that they received a report from dr.Kevin hanz of hanz aesthetic plastic surgery indicating a patient experienced burns after a surgical procedure performed on (b)(6) 2022 in which renuvion was also used as part of the overall surgical procedure.Apyx medical contacted the surgeon on 15dec2022.The surgeon stated there was no device malfunction but that they believe renuvion may have caused or contributed to the patient's burns.

• Brand Name: RENUVION
• Common Device Name: RENUVION
• Manufacturer (Section D): APYX MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760
• Manufacturer (Section G): APYX MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760
• Manufacturer Contact: angela huber ; 5115 ulmerton road; clearwater, FL 33760 ; 7273842323
• MDR Report Key: 16036357
• Report Number: 3007593903-2022-00020
• Device Sequence Number: 5477652
• Product Code: GEI
• UDI-Device Identifier: 00607151050160
• UDI-Public: 00607151050160
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/22/2022

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
• Operator of Device: Health Professional
• Device Model Number: APYX-27-TP
• Device Catalogue Number: APYX-27-TP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2022
• Initial Report FDA Received Date: 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White