MAUDE Adverse Event Report: APYX MEDICAL CORPORATION RENUVION

Device Problems Off-Label Use (1494); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Burn(s) (1757); Skin Discoloration (2074)

Event Date 01/04/2022

Event Type  Injury  

Event Description

It was reported by the patient via the apyx medical website, that the patient is seeking aftercare information.She noted that she is 7 weeks post procedure from surface renuvion and still very burned and discolored.The patient had a dermal resurfacing procedure performed on (b)(6) 2022 which is an off-label use of the apyx medical device.The patient notes she is burned and discolored to her face, cheeks, jawline, temples, forehead and chin.This patient has a surgical history of a face lift in (b)(6) 2020.The patient was treated post procedure with hydrocortisone, retin-a and hydroquinone for two weeks.The patient prefers that we do not contact the performing surgeon.

• Brand Name: RENUVION
• Type of Device: RENUVION
• Manufacturer (Section D): 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: 13710695
• MDR Text Key: 286861907
• Report Number: 3007593903-2022-00008
• 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: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/04/2022

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/09/2022
• Initial Date FDA Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female