MAUDE Adverse Event Report: APYX MEDICAL CORPORATION RENUVION; ELECTROSURGICAL, CUTTING & COAGULATION &

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Numbness (2415)

Event Date 01/07/2018

Event Type  Injury  

Event Description

Reporter stated he had a liposuction of his neck in (b)(6) 2018 and a renuvion was used for the procedure.Since then he has been experiencing numbness in his neck.He tried contacting the doctor but he refused to pick up his call, see him or help him.He stated that he read an information in the fda that providers are not supposed to use this device.The doctors information is: dr, (b)(6).

• Brand Name: RENUVION
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION &
• Manufacturer (Section D): APYX MEDICAL CORPORATION
• MDR Report Key: 15044237
• MDR Text Key: 296167847
• Report Number: MW5110934
• 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: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White