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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Inflammation (1932)

Event Date 11/17/2022

Event Type  Injury  

Event Description

(b)(6) i have a six hour surgery which included three procedures.Face lift, eye lid lift and renuvion laser skin resurfacing.It has been six months and my face is still red and inflamed.As i read through all my paperwork it says the skin can sty red up to six months.The my plastic surgeon does not seem to care.I have tried numerous methods to decrease the redness.I have learned renuvion is not a good product.

• Brand Name: RENUVION LASER SKIN RESURFACING
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): APYX MEDICAL CORPORATION
• MDR Report Key: 16963027
• MDR Text Key: 315735116
• Report Number: MW5117711
• 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: 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2023
• 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: TURMERIC.
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 67 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White