MAUDE Adverse Event Report: APYX MEDICAL CORPORATION RENUVION

Model Number APYX-27-TP

Device Problems Improper or Incorrect Procedure or Method (2017); Patient Device Interaction Problem (4001)

Patient Problem Fibrosis (3167)

Event Date 10/24/2022

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 304191966
• Report Number: 3007593903-2022-00019
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607151050160
• UDI-Public: 00607151050160
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 10/26/2022
• 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): Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic
• Patient Race: White