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

Model Number APYX-27-TP

Device Problem Insufficient Information (3190)

Patient Problem Nerve Damage (1979)

Event Date 08/01/2022

Event Type  Injury  

Event Description

Patient states procedure was over a year ago.Bilateral numbness/tingle to arms wrist to armpit.No hand numbness.Patient states sensation intact to hands.

Manufacturer Narrative

The patient has long term nerve damage in the most distal portion of her arm.Her extremities remain functional.The patient had a procedure involving combined treatments of liposuction, inmode morpheus 8 micro needling, and renuvion.Temporary and/or permanent sensory or motor nerve injury is a known potential complication for the three technologies used.The patient had a very high total kilojoules of energy delivered to the affected area, and that energy as well as the additional treatment modalities including inmode morpheus 8 micro needling procedure could have contributed in the nerve damage.It is possible that any of these technologies or a combination of the three could have contributed to the patient injury.

Manufacturer Narrative

The patient has long term nerve damage in the most distal portion of her arm.Her extremities remain functional.The patient had a procedure involving combined treatments of liposuction, inmode morpheus 8 micro needling, and renuvion.Temporary and/or permanent sensory or motor nerve injury is a known potential complication for the three technologies used.The patient had a very high total kilojoules of energy delivered to the affected area, and that energy as well as the additional treatment modalities including inmode morpheus 8 micro needling procedure could have contributed to the nerve damage.It is possible that any of these technologies or a combination of the three could have contributed to the patient's injury.

• Brand Name: RENUVION APR HANDPIECE
• Type of Device: ELECTROSURGICAL HANDPIECE
• Manufacturer (Section D): APYX MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760 4004
• Manufacturer (Section G): APYX MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760 4004
• Manufacturer Contact: graham cuthbert ; 5115 ulmerton road; clearwater, FL 33760-4004
• MDR Report Key: 17995649
• MDR Text Key: 326379338
• Report Number: 3007593903-2023-00007
• 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: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/06/2023

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: APYX-27-TP
• Device Catalogue Number: APYX-27-TP
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/08/2023
• Initial Date FDA Received: 10/24/2023
• Supplement Dates Manufacturer Received: 08/08/2023
• Supplement Dates FDA Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: VASER ULTRASOUND ASSISTED LIPO, INMODE MORPHEUS 8.
• Patient Outcome(s): Other
• Patient Sex: Female