MAUDE Adverse Event Report: APYX MEDICAL CORPORATION RENUVION

Model Number	APYX-270BPP
Medical Device Problem Codes	Use of Device Problem (1670); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Burn(s) (1757); Full thickness (Third Degree) Burn (2696); Blister (4537)
Date of Event	10/09/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent liposuction and sub-dermal coagulation on (b)(6) 2021.During the procedure vaser liposuction was performed at 70% followed by sub-dermal coagulation.The surgeon performed multiple treatment strokes over the same marking which was immediately stopped by the apyx medical clinical representative and was explained the rationale that this does not allow for thermal relaxation.The surgeon had performed 3 strokes over one particular point (originating approximately 330/340 degrees cranial from right inguinal insertion site which again the clinical representative had asked the surgeon to immediately stop doing.However, when they turned the patient the surgeon pointed out 3 dark red stroke marks on the dermis which was the exact point that this over treatment occurred of which he was informed of.The surgeon performed 6 passes over upper abdomen from left infra-mammary insertion site (not crosshatching).However, it was suggested to perform less due to previous complications and to err on the side of caution.It was also observed that the surgeon was not using the correct clockwise technique and some strokes were less than 2 cm apart.He was also repeating some strokes and was again asked if he could stop until the clinical representative again explained the rationale of this according to apyx sub dermal coagulation techniques and considerations.At times it was observed that end hits were performed which was also stopped and was explained after feeling the dermis to pull back 1 cm before activating as he was also using apyx-270bpp.The clinical representative also explained that the passes appeared very superficial and if treating with 6 passes then treatment should be in multiple planes.The joule counter in each area was utilized to ensure the generator was delivering correctly.This patient sustained full thickness burns with sloughing.

• Brand Name: RENUVION
• Common Device Name: RENUVION
• Manufacturer (Section D): APYX MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760 4004
• MDR Report Key: 12681007
• Report Number: 3007593903-2021-00019
• Device Sequence Number: 1364261
• Product Code: GEI
• UDI-Device Identifier: 00607151050061
• UDI-Public: 00607151050061
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K151325
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/09/2021

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-270BPP
• Device Catalogue Number: APYX-270BPP
• Device Lot Number: 0421M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2021
• 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: Other
• Patient Age: 28 YR
• Patient Weight: 73