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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fever (1858); Tachycardia (2095); Malaise (2359); Unspecified Respiratory Problem (4464)

Event Date 08/20/2020

Event Type  Injury  

Event Description

I had a liposuction and renuvion j plasty for skin tightening on my back and waist.I don't know exactly what happened but when they were trying to wake me up from anesthesia i couldn't breathe.Don't know how the anesthesiologist and the plastic surgeon handled it but i was kept several more hours at the surgery center and my sister that had come to pick me up didn't understand why it was taking so long.After 4 days i was feeling very sick and my pulse had reached 145 per minute and could hear my heart beat loud and rapidly and had high fever so i was admitted to (b)(6).I had to stay at the hospital for a few days.None of the doctors could understand exactly what happened to me.They did put me on antibiotics just in case even though all the cultures came back negative.I really think it was the renuvion that did this to me.I had to get a revision done a few months after the surgery but only had them use the renuvion on the right side of my back since i thought that it was responsible for the heart issue and fever i had.Please investigate renuvion further.What i experienced was a complete nightmare and from what my gp said is that i could've easily died from this.I'm not sure of the exact date of my surgery but can provide more details if need be.I am also using an alias for privacy reasons.Fda safety report id# (b)(4).

• Brand Name: RENUVION J PLASTY
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): APYX MEDICAL CORPORATION
• MDR Report Key: 15113125
• MDR Text Key: 296786381
• Report Number: MW5111133
• 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: 07/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White