MAUDE Adverse Event Report: APYX MEDICAL CORPORATION RENUVION

Model Number	APYX-27-TP
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Adhesion(s) (1695)
Date of Event	12/09/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by dr.(b)(6) that he performed a subdermal coagulation procedure with the apyx-27-tp to the submental area on (b)(6) 2021.This patient has no medical history and no previous procedures were performed to the treated area.The generator settings were at 60% gas and 1.5 liters of flow and four passes were performed.The insertion sites were one at each inferior earlobe and one the chin midline each bigger than 8 mm.Infiltration was infused of 400-450 cc and a basket-type cannula was used for undermining.The residual gas was aspirated after the treatment.Post procedure the patient presented with fibrous bands to the treated area and is dissatisfied.The patient has had a massage to the treated area as well as one corticosteroid injection of triamvirgi/kenacort.An additional injection is planned in one month.The surgeon noted there was no device malfunction.

• 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: 13359012
• Report Number: 3007593903-2022-00004
• Device Sequence Number: 4983974
• Product Code: GEI
• UDI-Device Identifier: 00607151050160
• UDI-Public: 00607151050160
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/18/2022

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-27-TP
• Device Catalogue Number: APYX-27-TP
• Device Lot Number: UNKNOWN
• 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: 01/12/2022
• Initial Report FDA Received Date: 01/26/2022
• 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: Required Intervention
• Patient Sex: Female