MAUDE Adverse Event Report: APYX MEDICAL CORPORATION RENUVION

Model Number	APYX-RS3
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	05/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
An apyx medical sales representative reported on 13feb2023 that they received a report from (b)(6) cosmetic surgery indicating a patient experienced burns after a surgical procedure performed on (b)(6) 2022 in which renuvion was also used as part of the overall surgical procedure.Apyx medical contacted the office on 01mar2023.The surgeon stated there was no device malfunction but that they believe renuvion, used in conjunction with vaser liposuction, may have caused or contributed to the patient's burns.
Additional Manufacturer Narrative
There was no malfunction observed during the procedure.However, the doctor did state he believes the renuvion generator may have caused or contributed to the patient's burns.The generator has been received by apyx medical and is currently being evaluated by the complaint investigation team.This report was initially sent to an apyx medical sales representative who did not report the event to the complaint handling unit.That sales representative is longer employed by apyx medical.The facility reported the event to the new apyx medical sales representative who reported the issue to the complaint handling unit and stated that the facility initially reported the issue to the previously employed apyx medical sales representative.As more information becomes available, including the results of the generator evaluation, a supplemental report will be filed as appropriate.

• Brand Name: RENUVION
• Common Device Name: RENUVION
• Manufacturer (Section D): APYX MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760
• Manufacturer (Section G): APYX MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760
• Manufacturer Contact: angela huber ; 5115 ulmerton road; clearwater, FL 33760 ; 7273842323
• MDR Report Key: 16601548
• Report Number: 3007593903-2023-00001
• Device Sequence Number: 7118700
• Product Code: GEI
• UDI-Device Identifier: 00607151050115
• UDI-Public: 00607151050115
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/23/2023

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-RS3
• Device Catalogue Number: APYX-RS3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2022
• Initial Report FDA Received Date: 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female