MAUDE Adverse Event Report: APYX MEDICAL CORPORATION RENUVION

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problem Insufficient Information (4580)

Event Date 06/03/2020

Event Type  Injury  

Event Description

It was reported by the patient via the apyx medical website that a plastic surgeon (name not provided) used renuvion to perform a mini-lift to her upper neck on (b)(6) 2020 and the patient is not satisfied with the result.Previous to this procedure the patient did not have any procedures to her face or neck.The patient claims the procedure caused tethering, and loose skin under her neck.Subsequently, the surgeon attempted to correct the treated area on (b)(6) 2021 by removing excess skin under the chin.The patient felt there was some improvement but not a significant amount as she still has a small amount of tethering and loose skin.In (b)(6) 2021 the same surgeon injected bellafil in the hopes of stimulating collagen growth to tightened skin.The surgeon also plans to perform rf micro needling, which is scheduled in (b)(6) 2022 in attempt to tighten the skin.The patient has inquired about having an upper neck lift as she has researched on her own that the may resolve the issue of sagging skin.However, the surgeon will not perform another surgery on this patient.This patient is seeking answers as to what will correct her tethered and sagging skin.This patient was also under the impression that renuvion may cause fat loss which could contribute to skin laxity.She feels her upper neck looks worse that before the procedure.This event was communicated to a member of the apyx medical corporation advisory board, dr.(b)(6).She reiterated the purpose of subdermal coagulation and how the procedure works to target the connective tissue in all layers, especially around and running through fat, under the skin, to provide tissue contraction.Dr.(b)(6) went on to note that muscle tightening and skin excision that the patient underwent addresses the components of tissue excess or deeper muscle layers being lax.The bellafil injections to promote collagen/elastin growth within the dermis will provide increased firmness.The plan for the rf micro needling from the surface will help reduce surface laxity within the skin-but usually requires a series of sessions to be effective.She made a recommendation that topical products would be beneficial including spf to continue protecting from environmental damage, topical hyaluronic acid and retinoids (low strength because neck skin is very sensitive).However, her surgeon can guide her based off of her current skin care regimen.Dr.(b)(6) also recommend an oral collagen and oral hyaluronic acid supplements and mentioned that a series of bidirectional barbed pdo threads along your jawline and submandibular space would pull the skin laterally to possibly smooth the submental area.Unfortunately, dr.(b)(6) does not know that there is more beyond this to try as there is a finite amount of tissue toning that can be accomplished as the skin ages.The name of the surgeon who performed the procedure was requested for contact as additional information is needed to conduct a thorough investigation.However, the patient did not want to disclose the surgeon's name.Based on the reported information, this is an unexpected cosmetic outcome.However, an additional surgical procedure and injection of a collagen stimulating product was necessary to improve the patient's outcome.

• Brand Name: RENUVION
• Type of Device: RENUVION
• 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: aylin canlar ; 5115 ulmerton road; clearwater, FL 33760-4004 ; 7273842323
• MDR Report Key: 13151661
• MDR Text Key: 283147712
• Report Number: 3007593903-2021-00035
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/13/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female