MAUDE Adverse Event Report: APYX MEDICAL CORPORATION RENUVION

Model Number APYX-15-TP

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

Patient Problems Inflammation (1932); Skin Infection (4544); Skin Inflammation/ Irritation (4545)

Event Date 11/01/2021

Event Type  Injury  

Event Description

It was reported to apyx medical corporation that a patient underwent a superficial versa procedure followed by subdermal coagulation with renuvion to the neck and jowl on (b)(6) 2021.Four passes were performed at 60% power and 1.5l flow.Subsequently, the patient presented with inflammation and fever.The patient was started on antibiotic therapy of keflex 500 mg to treat the fever and swelling.However, the inflammation has not resolved.Based on the reported information, there was no alleged malfunction of the device.However, the patient did require medical intervention.

• Brand Name: RENUVION
• Type of Device: RENUVION
• Manufacturer (Section D): APYX MEDICAL CORPORATION; 5115 ulmterton road; clearwater FL 33760 4004
• Manufacturer Contact: aylin canlar ; 5115 ulmerton road; clearwater, FL 33760-4004 ; 7273842323
• MDR Report Key: 12882001
• MDR Text Key: 281318073
• Report Number: 3007593903-2021-00031
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2021
• 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
• Date Manufacturer Received: 11/01/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Female