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

Patient Problems Inflammation (1932); Scar Tissue (2060); Wrinkling (2613); Skin Burning Sensation (4540); Swelling/ Edema (4577)

Event Date 10/04/2022

Event Type  Injury  

Event Description

On (b)(6) 2022 liposuction and sculpting of abdomen, flank and back was performed by dr.(b)(6).Body tite and j plasma were used during this surgery.Immediately after, i had burning of the skin, brown hyperpigmentation, inflammation, water retention and scarring.After multiple corrective measures, skin is currently still hyperpigmented and wrinkled looking.Reference report: mw5146219.

• Brand Name: JPLASMA
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): APYX MEDICAL CORPORATION
• MDR Report Key: 17833715
• MDR Text Key: 324720646
• Report Number: MW5146220
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2023
• 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
• Patient Outcome(s): Disability
• Patient Sex: Female