MAUDE Adverse Event Report: APYX MEDICAL CORPORATION RENUVION

Model Number APYX-15-TP

Device Problems Use of Device Problem (1670); Patient Device Interaction Problem (4001)

Patient Problems Burn(s) (1757); Scar Tissue (2060)

Event Date 02/24/2022

Event Type  Injury  

Event Description

Patient underwent vaser liposuction followed by subdermal coagulation with renuvion to the submental area.One pass with renuvion was performed at generator settings of 80% power and 1.5 liters of flow.Speed, spacing, infiltration solution and amount, treatment plane depths, and aspiration amount was requested but noted as unknown by the surgeon's office.Patient wore a garment post procedure and followed after care instructions per her surgeon's protocol.However, three days post procedure, a burn to the treated area was noticed.The degree of burn was not confirmed by the surgeon.Multiple steroid injections of kenalog were administered by the surgeon to the affected area on (b)(6) 2022.Additionally, micro-needling was performed on (b)(6) 2022 in effort to treat the burn.Although the surgeon noted that the patient was healing, the patient has a visible scar post procedure and treatments as a result of the burn.The cause of the burn is due to end hits.The end hits may have been caused by the apyx medical device or the vaser device or a combination of both during the procedure.End hits are not a recommended technique per the apyx medical technique considerations which are disclosed during customer training.As it is unknown if the end hits were caused or contributed by the vaser device or by the apyx medical device, this event is deemed reportable as a use error.

• Brand Name: RENUVION
• Type of Device: RENUVION
• Manufacturer (Section D): APYX MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760
• Manufacturer (Section G): APYX MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760
• Manufacturer Contact: aylin canlar ; 5115 ulmerton road; clearwater, FL 33760 ; 7273842323
• MDR Report Key: 15476014
• MDR Text Key: 300582710
• Report Number: 3007593903-2022-00017
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607151050153
• UDI-Public: 00607151050153
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/19/2022

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
• Device Operator: 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
• Initial Date Manufacturer Received: 08/24/2022
• Initial Date FDA Received: 09/24/2022
• 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 LIPOSUCTION
• Patient Outcome(s): Required Intervention; Disability
• Patient Sex: Female