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

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 01/03/2024

Event Type  Injury  

Event Description

The patient sustained a 2nd degree - b deep thickness burn on her abdomen after microaire power assisted liposuction (pal) was performed and in which renuvion was used as part of the overall surgical procedure.

Manufacturer Narrative

The device was discarded and not available for evaluation.Initially, the doctor believed the injury could have been the result of using an abdominal binder and treated with anticoagulant (lidocaine and heparin).The patient had the procedure done in ecuador and returned to the united states shortly afterwards due to the political events in the country and is no longer under the care of the physician who performed the procedure.The patient is being treated with antibiotic creams and will go to a specialized clinic.Temporary and/or permanent injury as a result of a burn is a known potential complication for this technology and treatment.

• Brand Name: RENUVION
• 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 33760
• Manufacturer Contact: graham cuthbert ; 5115 ulmerton road; clearwater 33760 ; 7278038554
• MDR Report Key: 18681270
• MDR Text Key: 335073278
• Report Number: 3007593903-2024-00001
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: EC
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MICROAIRE POWER ASSISTED LIPOSUCTION (PAL)
• Patient Outcome(s): Other
• Patient Age: 19 YR
• Patient Sex: Female