MAUDE Adverse Event Report: APYX MEDICAL CORPORATION RENUVION; ELECTROSURGICAL GENERATOR

Model Number APYX-RS3

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 09/19/2023

Event Type  Injury  

Manufacturer Narrative

The patient received a 3rd degree burn on her neck.Temporary and/or permanent injury as a result of a burn is a known potential complication for this technology and treatment.The initial reporter, who was present during the time of the case, stated the doctor said he could have been too superficial during treatment.It is possible the providers technique could have contributed to the patient injury.

Event Description

The patient received a 3rd degree burn on her neck.

• Brand Name: RENUVION
• Type of Device: ELECTROSURGICAL GENERATOR
• Manufacturer (Section D): APYX MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760 4004
• Manufacturer (Section G): APYX MEDICAL; 5115 umerton rd; clearwater FL 33760
• Manufacturer Contact: graham cuthbert ; 5115 ulmerton road; clearwater, FL 33760-4004
• MDR Report Key: 17995657
• MDR Text Key: 326381200
• Report Number: 3007593903-2023-00009
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607151050115
• UDI-Public: 00607151050115
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192867
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/24/2023

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
• Device Operator: Health Professional
• Device Model Number: APYX-RS3
• Device Catalogue Number: APYX-RS3
• Device Lot Number: BV1222007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2023
• Initial Date FDA Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: EMLA, PRONTOSAN WOUND GEL AND DRACOFOAM
• Patient Outcome(s): Other
• Patient Sex: Female