MAUDE Adverse Event Report: APYX MEDICAL CORPORATION RENUVION

Model Number	APYX-27-TP
Medical Device Problem Codes	Use of Incorrect Control/Treatment Settings (1126); Use of Device Problem (1670); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pneumothorax (2012); Retroperitoneal Hemorrhage (4483)
Date of Event	09/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient had a 360 liposuction procedure to the abdomen, flanks, lipo-abdominoplasty with an umbilical float, repair of diastasis recti and liposuction of trunk, mid back/bra roll.And subdermal coagulation on (b)(6) 2021.It was noted that this was the surgeon's first sub-dermal coagulation procedure with renuvion.Subsequently, on (b)(6) 2021, the patient was admitted to the hospital for dehydration and severe gastritis as a result of the procedures.Upon admission to the hospital, the patient had a ct scan performed which showed a left pneumothorax and pneumoperitoneum.During the procedure, the surgeon recalled hitting a significant bump against the sixth or seventh rib that would have resulted in a penetration of the posterior fascia and musculature.The patient developed a retro-peritoneal bleed requiring a transfusion of 2 units of packed red blood cells.Subsequently, the patient developed an infection in the retro-peritoneum requiring a percutaneous draining and intravenous antibiotics.The patient is recovering well.

• Brand Name: RENUVION
• Common Device Name: RENUVION
• Manufacturer (Section D): APYX MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760 4004
• MDR Report Key: 12683862
• Report Number: 3007593903-2021-00020
• Device Sequence Number: 13794057
• Product Code: GEI
• UDI-Device Identifier: 00607151050160
• UDI-Public: 00607151050160
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/22/2021

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 10/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening