MAUDE Adverse Event Report: APYX MEDICAL CORPORATION RENUVION

Model Number	APYX-15-TP
Medical Device Problem Codes	Use of Device Problem (1670); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Nerve Damage (1979)
Date of Event	01/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the surgeon that a (b)(6) year old female patient presented with unilateral marginal mandibular nerve injury, two weeks post liposuction and renuvion treatment to the submental area.Undermined was performed in the subcutaneous plane of the neck through a submental crease small incision with a 3.7mm single hole cannula.About 400 cc of wetting solution was instilled and a total of 6 passes were performed.Post procedure, the patient was placed in a compression neck wrap.The surgeon's main concern was to be reassured this would not be permanent.This was the surgeon's first use with renuvion.The patient will consult with a plastic surgeon for a possible injection of a toxin to the unaffected side for symmetry until the nerve injury improves.Currently, the patient was prescribed an oral steroid in effort to speed the healing time of the nerve injury.Additional information was received on 2/14/2022 providing the device information, apyx-15-tp, lot#0000013937.The surgeon used a 3.7 mm single hole cannula for undermining, infiltrated with 400cc of fluid.The location of insertion sites were at the subcutaneous plane of the neck, through a submental crease incision.Six passes at 60% gas and 1.5 liters of flow of helium and a total of 6.3kj.Neck compression garment was applied post procedure.

• Brand Name: RENUVION
• Common Device Name: RENUVION
• Manufacturer (Section D): APYX MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760 4004
• Manufacturer Contact: aylin canlar ; 5115 ulmerton road; clearwater, FL 33760-4004 ; 7273842323
• MDR Report Key: 13545465
• Report Number: 3007593903-2022-00006
• Device Sequence Number: 14000046
• Product Code: GEI
• UDI-Device Identifier: 00607151050153
• UDI-Public: 00607151050153
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/11/2022

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-15-TP
• Device Catalogue Number: APYX-15-TP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 02/16/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 34 YR
• Patient Sex: Female