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

Model Number	APYX-27-TP
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Nerve Damage (1979)
Date of Event	08/01/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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.
Additional 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
• Common Device Name: 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
• Report Number: 3007593903-2023-00007
• Device Sequence Number: 20364222
• Product Code: GEI
• UDI-Device Identifier: 00607151050160
• UDI-Public: 00607151050160
• Combination Product (Y/N): N
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: APYX-27-TP
• Device Catalogue Number: APYX-27-TP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/08/2023
• Supplement Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: VASER ULTRASOUND ASSISTED LIPO, INMODE MORPHEUS 8.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female