MAUDE Adverse Event Report: APYX MEDICAL CORPORATION RENUVION; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Device Problems Temperature Problem (3022); Patient Device Interaction Problem (4001)

Patient Problems Scar Tissue (2060); Partial thickness (Second Degree) Burn (2694)

Event Date 12/21/2021

Event Type  Injury  

Event Description

Renuvion treatment lead to severe burns and permanent scarring.

• Brand Name: RENUVION
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): APYX MEDICAL CORPORATION
• MDR Report Key: 16911100
• MDR Text Key: 315106108
• Report Number: MW5117457
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/07/2023

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/10/2023
• Patient Sequence Number: 1
• Treatment: ATORVASTATIN, CLIMARA PRO.; CALCIUM, D3, B12, MULTI-VITAMIN.
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White