MAUDE Adverse Event Report: APYX MEDICAL CORPORATION RENUVION

Model Number	APYX-27-TP
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Burn(s) (1757); Scar Tissue (2060)
Date of Event	07/31/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient sustained burns to the trunk and bilateral flank areas post subdermal coagulation procedure.It was also noted that this was the first time the surgeon used renuvion.

• Brand Name: RENUVION
• Common Device Name: RENUVION
• Manufacturer (Section D): APYX MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760 4004
• MDR Report Key: 12369587
• Report Number: 3007593903-2021-00012
• Device Sequence Number: 4536375
• Product Code: GEI
• UDI-Device Identifier: 00607151050160
• UDI-Public: 00607151050160
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/24/2021

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: 08/03/2021
• Initial Report FDA Received Date: 08/26/2021
• 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: Required Intervention