MAUDE Adverse Event Report: APYX MEDICAL CORPORATION RENUVION APR HANDPIECE; ELECTROSURGICAL HANDPIECE

Model Number	APEX-27-TP
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A female patient experienced a burn to their jaw in which renuvion was used as part of the overall surgical procedure.
Additional Manufacturer Narrative
The patient received what the physician called a small (6mm x3mm) 3rd degree burn on her jaw during a procedure in which liposuction and renuvion were used as part of the overall surgical procedure.Debridement was performed in the doctor's office, and the physician believes it will not lead to any significant cosmetic deformity.Temporary and/or permanent injury as a result of a burn is a known potential complication for this technology and treatment.

• Brand Name: RENUVION APR HANDPIECE
• Common Device Name: ELECTROSURGICAL HANDPIECE
• Manufacturer (Section D): APYX MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760
• Manufacturer (Section G): APYX MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760
• Manufacturer Contact: graham cuthbert ; 5115 ulmerton road; clearwater, FL 33760
• MDR Report Key: 18260113
• Report Number: 3007593903-2023-00012
• Device Sequence Number: 11751249
• Product Code: GEI
• UDI-Device Identifier: 00607151050160
• UDI-Public: 00607151050160
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K191542
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/04/2023

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: APEX-27-TP
• Device Catalogue Number: APEX-27-TP
• Device Lot Number: 0000023052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LIPOSUCTION (DEVICE NOT SPECIFIED)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Sex: Female