MAUDE Adverse Event Report: APYX MEDICAL CORPORATION APYX ONE CONSOLE; ELECTROSURGICAL GENERATOR

Model Number APYX-ONE

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 10/20/2023

Event Type  Injury  

Event Description

A female patient experienced a burn after power assisted liposuction (pal) was performed to their arm and in which renuvion was used as part of the overall surgical procedure.

Manufacturer Narrative

The patient received a 3rd degree burn on her arm.Temporary and/or permanent injury as a result of a burn is a known potential complication for this technology and treatment.Attempts to gather additional information from the doctor were not successful.

• Brand Name: APYX ONE CONSOLE
• Type of Device: ELECTROSURGICAL GENERATOR
• 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: 18159858
• MDR Text Key: 328402330
• Report Number: 3007593903-2023-00010
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607151050221
• UDI-Public: 00607151050221
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221830
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: APYX-ONE
• Device Catalogue Number: APYX-ONE
• Device Lot Number: 35944
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2023
• 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: MICROAIRE POWER-ASSISTED LIPOSUCTION (PAL)
• Patient Outcome(s): Other
• Patient Sex: Female