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

Patient Problems Scar Tissue (2060); Skin Discoloration (2074); Deformity/ Disfigurement (2360)

Event Date 10/06/2023

Event Type  Injury  

Event Description

Patient had surgery performed by a surgeon at a different establishment.She says "renuvion" was used to contour her abdomen at the time of fat grafting for breast reconstruction.She developed severe scarring of subcutaneous tissues, discoloration of skin, and disfiguration of a 16x9cm area of the upper abdomen.She will need to undergo reconstructive surgery to correct acquired deformity.

• Brand Name: RENUVION
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): APYX MEDICAL CORPORATION
• MDR Report Key: 18518221
• MDR Text Key: 333047185
• Report Number: MW5150219
• 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: Physician
• Type of Report: Initial
• Report Date: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White