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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Sleep Dysfunction (2517)

Event Date 08/16/2022

Event Type  Injury  

Event Description

On or around august 16, i received liposuction in my back bra roll area and lower back, along with j plasma for skin tightening.My procedure was performed by dr.(b)(6) at (b)(6).Since the procedure i've been in pain and have a difficult time sleeping at night and performing regular routine duties because of it.I've had multiple follow up appointments with dr.(b)(6) and had to go to the emergency room due to the pain and movement restrictions i was experiencing.I've also had to have more pain medication (ineffective) called into my pharmacy.During my last visit with dr.(b)(6) (about a week or so ago), it was suggested that i go to my primary doctor to be referred to a neurologist and that a note would be written to my primary doctor.I have yet to hear back from anyone yet, but plan to follow up with my primary doctor and dr.(b)(6) again this morning.Fda safety report id # (b)(4).

• Brand Name: RENUVION/J PLASMA
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): APYX MEDICAL CORPORATION
• MDR Report Key: 15744419
• MDR Text Key: 303278595
• Report Number: MW5113095
• 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: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Treatment: PRENATAL VITAMINS.
• Patient Outcome(s): Other
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American