MAUDE Adverse Event Report: APYX MEDICAL CORPORATION RENUVION

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

Patient Problem Swelling/ Edema (4577)

Event Type  Injury  

Event Description

It was reported by the distributor that on 18oct2021, a (b)(6) patient underwent liposuction to the abdomen (800cc) and inner thighs (1liter).Infiltration of 1 liter was given to inner thighs and 500cc to abdomen.Renuvion treatment was then performed, 3 passes at 70% gas and 2.5l flow to the thighs and 3 passes to the abdomen at 75% gas and 2.5l flow.A girdle was placed on the patient.However, post procedure, the patient experienced generalized edema to the lower limbs, pubis and moderate abdominal edema.There are no signs of deep vein thrombosis, she has good mobility, no pain just very swollen calves and ankles.This patient has a history of previous liposuction and hypothyroidism and is treated with thyroxine.Undermining was performed with asp-150-bps, treatment planes were two intermediate and one superficial.Aspiration was performed.The patient edema was treated with lasix and non-steroidal anti-inflammatory medication.The patient will also start physio-drainage for two weeks.The patient is doing better and there are no long term health effects.The surgeon does believe that the device caused or contributed to the edema.

• Brand Name: RENUVION
• Type of Device: 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: 12845018
• MDR Text Key: 283610181
• Report Number: 3007593903-2021-00030
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/28/2021
• Initial Date FDA Received: 11/19/2021
• 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 Age: 33 YR
• Patient Sex: Female