MAUDE Adverse Event Report: APYX MEDICAL CORPORATION RENUVION

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

Patient Problems Abdominal Pain (1685); Scar Tissue (2060); Seroma (2069)

Event Date 10/07/2021

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2021, a patient underwent liposuction to the flanks and subdermal coagulation with renuvion to the patient's abdomen only.Insertion sites were at the lower midline/upper pubis and umbilicus, approximately 1 cm each.Aspiration was performed and 1 liter of tumescent was administered.1 liter of fat was aspirated (slurry or liquid fat) via power assisted liposuction.It was noted that the patient did not have much adipose tissue, therefore, the target plane was intermediate.Foam compression was applied to the patient post procedure for at least 3 weeks.Following the 3 weeks, the patient was given the opportunity to wear compression as needed.Subsequently, the patient called the surgeon regarding swelling.The patient was seen at the surgeon's office and a seroma was noted which was drained once on (b)(6) 2021.Since then, the patient has had two injections of steroids to the larger edematous areas.In (b)(6) (exact date not provided), the patient sought emergency medical attention as she was "symptomatic" and had more pain.Therefore, the patient did not want to wait for the scheduled ultrasound.A ct scan was performed and showed a fair amount of inflammation to the areas where the steroid was administered.The patient's abdomen appears rippled and uneven.The steroid injections along with time seem to be helping.The surgeon is anticipating the patient will need a release of scar tissue at some point.The surgeon believes there was too much heat despite the large amount of fluid or perhaps there was too much fluid.The flanks area did very well (almost perfect).However, renuvion was not treated at the flanks.It was also noted that on the patient's way home from surgery, a deer jumped in front of the car causing an abrupt stop after which the patient had more pain.The surgeon is sure that this incident did not help the situation.

• 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: 13288429
• MDR Text Key: 284004072
• Report Number: 3007593903-2022-00003
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2022
• 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: 12/21/2021
• 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): Other
• Patient Sex: Female