MAUDE Adverse Event Report: APYX MEDICAL CORPORATION RENUVION

Model Number APYX-27-TP

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

Patient Problem Chest Pain (1776)

Event Date 01/23/2022

Event Type  Injury  

Event Description

It was reported that a (b)(6) female patient with a history of rhinoplasty and breast implants, underwent liposuction followed by renuvion treatment.Undermining was performed with vibrasat pro and there were 2 liters of 1mg of adrenaline infused.3 passes on antegrade and retrograde were performed to the abdomen, thighs, back, arms and buttocks.6.5 liters of asperation was performed on multiple locations for 3.5 hours.The procedure was completed uneventful.However, the following day, the patient complaint of violent chest and dorsal pain while showering.The patient suffered from pain for four days and eventually fainted.The patient was hospitalized due to pain.It was further determined that there was only one single incision site at the arms where treatment was performed.The patient was scanned and a pneumomediastinum was diagnosed around right chest and heart.There was no embolism and no oxygen compromise.The patient was only treated for pain.The patient is recovering at home.The likely cause of this incident is due to not enough adequate incision sites for gas egress.It was further determined that the surgeon performs 3 passes and uses the liposuction cannula for suction.Per apyx medical, advisory board member, suction with a liposuction cannula can compress tissue and block egress points.Therefore, true undermining is important, otherwise compression of tissue occurs trapping gas and causing direct access to the mediastinum.

• 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: 13695868
• MDR Text Key: 287119792
• Report Number: 3007593903-2022-00007
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607151050160
• UDI-Public: 00607151050160
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K191542
• 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
• Report Date: 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: APYX-27-TP
• Device Catalogue Number: APYX-27-TP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31 YR
• Patient Sex: Female