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

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Hematoma (1884); Low Blood Pressure/ Hypotension (1914); Scar Tissue (2060); Skin Discoloration (2074); Wrinkling (2613)

Event Date 08/16/2019

Event Type  Injury  

Event Description

Night of surgery i have a serious blood pressure drop.Next morning for post op they take off compression garment and i have tons of wrinkles on my abdomen (pictured).Then 2 weeks later my board certified "plastic surgeon" tries to fix with lipo and then i get a hematoma.A year later tummy tuck in attempt to fix.I still have pink discoloration from the heat of the vaser and have tried 4 laser treatments, and the pink burn marks are still present.I also have some faint lines above my belly from internal scar tissue from the previous damage.Fda safety report id# (b)(4).

• Brand Name: J-PLASMA
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): APYX MEDICAL CORPORATION
• MDR Report Key: 14416287
• MDR Text Key: 291960304
• Report Number: MW5109739
• 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: 05/12/2022

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/16/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Life Threatening; Required Intervention; Hospitalization
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White