MAUDE Adverse Event Report: APYX MEDICAL CORPORATION RENUVION

Model Number APYX-15-TP

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Patient Device Interaction Problem (4001)

Patient Problems Adhesion(s) (1695); Wrinkling (2613)

Event Date 05/18/2021

Event Type  Injury  

Event Description

It was reported that a patient underwent a subdermal coagulation trial case of upper abdomen only.The patient's outcome resulted in upper abdominal adhesions due to inappropriate use by the surgeon.There was no reported performance issues with the handpiece or delivery generator.

• 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: 12306286
• MDR Text Key: 265971939
• Report Number: 3007593903-2021-00010
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607151050153
• UDI-Public: 00607151050153
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191542
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/02/2023
• Device Model Number: APYX-15-TP
• Device Catalogue Number: APYX-15-TP
• Device Lot Number: 1120J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2020
• 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): Disability
• Patient Age: 51 YR