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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bruise/Contusion (1754); Necrosis (1971); Partial thickness (Second Degree) Burn (2694)

Event Date 05/27/2022

Event Type  Injury  

Event Description

I had 360 degree liposuction and renuvion skin tightening to my abdomen.Shortly after surgery unusual bruising pattern was noted on my abdomen which i alerted my surgeon about.Evaluation revealed an area of necrosis.I was sent to hyperbaric treatments.Over the course of 2 weeks the bruising evolved and the skin changed and began to work with what appeared to be 2nd degree burns.I am still healing from the procedure.Fda safety report id # (b)(4).

• Brand Name: RENUVION
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): APYX MEDICAL CORPORATION
• MDR Report Key: 14946656
• MDR Text Key: 295498190
• Report Number: MW5110724
• 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: 07/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: TIROSINT; TRIAMTERENE/HCTZ; VALSARTAN
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Ethnicity: Hispanic