MAUDE Adverse Event Report: APYX MEDICAL CORPORATION RENUVION

Device Problems Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problem Skin Disorders (4543)

Event Date 02/24/2022

Event Type  Injury  

Event Description

It was reported by a plastic surgeon, dr.(b)(6) that a patient sought his medical attention after undergoing abdominal liposuction and renvuion treatment as part of a bbl procedure with an unidentified naturopathic health provider and was harmed.Dr.(b)(6) explained that this patient presented severely injured with permanent subdermal damage.The patient also stated that the appearance of her abdomen looked irregular shortly after the procedure and did not improve after several months.The patient stated the provider offered to "fix" the area but did not say how.Based on dr.(b)(6) exam and professional opinion - the area was severely over resected with liposuction and in the superficial plane, leaving denuded dermis.Renuvion was then applied to an over thinned out flap.This appears to be poor technique of liposuction combined with an inappropriate use of the technology in an overly-thinned flap.Per dr.(b)(6), this is not an issue with the device, rather the expected outcome with inadequately trained providers using the renuvion device inappropriately.Per dr.(b)(6), the only option for the patient is offer a full excision and closure with advancement (tummy tuck essentially).Based on the reported information, this is a reportable event as the patient sustained permanent damage to the dermis due to a use error with renuvion.

• 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: 13832031
• MDR Text Key: 288299424
• Report Number: 3007593903-2022-00009
• 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: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2022
• 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: 02/19/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female