MAUDE Adverse Event Report: APYX MEDICAL CORPORATION RENUVION

Model Number	APYX-27-TP
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Fibrosis (3167)
Date of Event	10/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by dr.Marrero that a patient was experiencing fibrosis after a surgical procedure performed on (b)(6) 2022 in which renuvion was also used as part of the overall surgical procedure.This report did not indicate when the patient presented with fibrosis.However, dr.Marrero reported this issue to apyx medical at four weeks post procedure.Based on the or record and the physician's comments, the physician admitted the training guidelines were not followed and overtreated the patient.Patient will require additional surgical treatment for the fibrosis.The surgeon noted there was no device malfunction.
Additional Manufacturer Narrative
On (b)(6) 2022, an apyx medical senior clinical operations specialist met with dr.Marrero and discussed best practices to prevent fibrosis in patients during future procedures.Dr.Marrero stated there was no product malfunction and they will be continuing to use renuvion in future procedures.

• Brand Name: RENUVION
• Common Device Name: RENUVION
• Manufacturer (Section D): APYX MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760
• Manufacturer (Section G): APYX MEDICAL; 5115 ulmerton road; clearwater FL 33760
• Manufacturer Contact: angela huber ; 5115 ulmerton road; clearwater, FL 33760 ; 7273842323
• MDR Report Key: 15852378
• Report Number: 3007593903-2022-00019
• Device Sequence Number: 5076873
• Product Code: GEI
• UDI-Device Identifier: 00607151050160
• UDI-Public: 00607151050160
• Combination Product (Y/N): N
• Initial Reporter State: PR
• 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): 11/22/2022

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
• Initial Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 11/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: 42 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic
• Patient Race: White