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

Model Number APEX-27-TP

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 10/26/2023

Event Type  Injury  

Event Description

A female patient experienced a burn to their jaw in which renuvion was used as part of the overall surgical procedure.

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
• Type of Device: 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
• MDR Text Key: 329670921
• Report Number: 3007593903-2023-00012
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607151050160
• UDI-Public: 00607151050160
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191542
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: LIPOSUCTION (DEVICE NOT SPECIFIED)
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Sex: Female