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

Model Number	APYX-RS3
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	09/19/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
The patient received a 3rd degree burn on her neck.

• Brand Name: RENUVION
• Common Device Name: 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
• Report Number: 3007593903-2023-00009
• Device Sequence Number: 6123097
• Product Code: GEI
• UDI-Device Identifier: 00607151050115
• UDI-Public: 00607151050115
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K192867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EMLA, PRONTOSAN WOUND GEL AND DRACOFOAM
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female