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

Device Problem Product Quality Problem (1506)

Patient Problems Scar Tissue (2060); Deformity/ Disfigurement (2360); Numbness (2415); Wrinkling (2613)

Event Date 10/09/2019

Event Type  Injury  

Event Description

I had the renuvion procedure done in 2019, to my upper abs my arms and my knees face and neck.While the face procedure was fine, i was left us a great deal of scar tissue.And the results only lasted for a year i did not see results that were at all good for four months.My knees are still numb and look far worse than they did before the procedure.They improved briefly for about three months, and then went drastically downhill.I now have knees that do not allow me to wear shorts without feeling incredibly self-conscious, when before i just had a few wrinkles.Now i have a divet in my knees.I went to another plastic surgeon and he told me it would cost (b)(6) to repair my knees with either filler and or reneva which i cannot afford.Also there is a definitive line at the top of my thigh where you can see where there was a stopping of treatment.In short they look horrible.My upper abs looked better for about three months and then slid downhill, the only thing that helped was to build up more muscle in my upper abs to undo the unevenness caused by the renuvion.My arms are worse (my upper arms), and still had numbness and very uneven texture and tone.Weight training which i don't like to do, is the only thing that made my arms look better.I'm sure this treatment works fine for people with liposuction it does not work on athletic or those with very little body fat.I have spoken with two other people who receive this same treatment, with similar body types as mine, thinner, low fat and we all say the same thing we could no longer wear shorts because it made everything worse.I don't expect anybody is going to fix anything but i do want to let you know that this treatment is being used very unsuccessfully on a large number of people with very disappointing results.To continue doing this procedure on people giving them false hope is wrong as well.I have worse skin tone everywhere.The results were 200% more skin laxity in treated area.Numbness on knees and arms.Upper abdomen was so much worse.Crept skin and mottled.Once a week or twice a week i've had to go get deep fascia blasting done at the cost of (b)(6) a session.I can't wear shorts.I work out two hours a day every day, and i am fighting a losing battle every doctor i've gone to said it will be a minimum of (b)(6) to get it back to 30% of where i was.

• Brand Name: RENUVION
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): APYX MEDICAL CORPORATION
• MDR Report Key: 16103382
• MDR Text Key: 306822975
• Report Number: MW5114175
• 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: 01/01/2023

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?: Yes
• Device Operator: Health Professional
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/04/2023
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White