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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Erythema (1840); Scar Tissue (2060); Burning Sensation (2146); Neuralgia (4413); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/19/2020

Event Type  Injury  

Event Description

A plastic surgeon name dr.(b)(6) used the j plasma/reunion device incorrectly.He used a high power (50% pass and a second 40% pass) on the perioral area.He also did two passes on my neck (30%).He did the entire face including my eyelids.I now have permanent hypertrophic scaring on my upper perioral region and below my lip and chin.The lower scar contracted and has pulled my lip down to expose the labial area of my lip.I required lubrication during the day due to dryness.My entire vermilion is scarred.I have erythema on my entire face.I have chronic severe nerve pain that required pain management.The burning pain radiates to my cheeks and eye area.I am hypersensitive to warmth, heat, cold and any pressure.It has impaired my ability to speak clearly and to eat certain foods.My quality of life plummeted after this surgery.

• Brand Name: RENUVION/JPLASMA
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): APYX MEDICAL CORPORATION
• MDR Report Key: 15933143
• MDR Text Key: 305134686
• Report Number: MW5113679
• 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: Patient
• Type of Report: Initial
• Report Date: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: SYNTHROID, ZOCOR, ZETIA, PERCOCET, GABAPENTIN.; TYLENOL, MULTIVITAMIN, CALCIUM, CHONDROITIN.
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White