MAUDE Adverse Event Report: APYX MEDICAL CORPORATION RENUVION

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Patient Device Interaction Problem (4001)

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)

Event Date 10/26/2021

Event Type  Injury  

Event Description

It was reported to apyx medical corporation that post subdermal coagulation procedure on the medial thighs, the patient experienced severe hypotension and decreased heart rate towards the end of the procedure.It was also noted that the patient did not have enough incision sites for gas egress in effort to make as few incisions as possible for "aesthetic reasons".The gas buildup during the procedure was the cause of the hypotension and decreased heart rate.The probable cause of this adverse event and use of equipment is due to lack of proper training and compliance with all the protocols of apyx medical corporation.

• Brand Name: RENUVION
• Type of Device: RENUVION
• Manufacturer (Section D): APYX MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760 4004
• Manufacturer (Section G): APYX MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760 4004
• Manufacturer Contact: aylin canlar ; 5115 ulmerton road; clearwater, FL 33760-4004 ; 7273842323
• MDR Report Key: 13008937
• MDR Text Key: 282260349
• Report Number: 3007593903-2021-00033
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/14/2021

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/22/2021
• Initial Date FDA Received: 12/15/2021
• 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): Life Threatening