MAUDE Adverse Event Report: APYX MEDICAL CORPORATION RENUVION

Device Problems Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Abscess (1690); Skin Infection (4544); Skin Inflammation/ Irritation (4545)

Event Date 09/15/2021

Event Type  Injury  

Event Description

It was reported that a patient underwent a renuvion treatment to the lower face and neck on (b)(6) 2021 with the apyx-15-tp with an unknown surgeon.However, one week prior to this event being reported to apyx medical corporation, this event was reported by another surgeon who treated the patient.This patient began presenting with redness to the lower left neck which has progressed to full neck erythema with drainage of purulent like fluid.18cc of fluid was drained from the patient's neck.The patient was seen again two weeks later with no issues.This is a thin and healthy patient who has been fully compliant with post procedure instructions.On (b)(6) 2021, the patient was given duricef, biaxin and a medrol dose pack.It was noted that the generator settings were at 75% gas and 1.5 liters of flow.6 passes were performed, with no suctions and pre-tunneling with a vaser 2.9mm 3 grove probe (30% v mode for 3 minutes).Although the available information does not reasonably suggest that the medical device may have caused or contributed to the reported injury as the device is sterile, this event will be reported to err on the side of caution.

• 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: 12830588
• MDR Text Key: 283315880
• Report Number: 3007593903-2021-00028
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• 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
• Date Manufacturer Received: 10/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Female