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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Scar Tissue (2060); Deformity/ Disfigurement (2360); Paresthesia (4421)

Event Date 07/31/2019

Event Type  Injury  

Event Description

I went in for liposuction on my stomach and the doctor told me that it would be pointless to do liposuction without j plasma.I was left with extreme pain and my entire stomach was left with dents and i lost feeling in my stomach.My skin was sensitive to the touch for 8 months i know i was burned now after doing more research.My stomach was left completely disfigured and i was told i have scar tissue internally like a leather belt from another doctor i went to correction to try.I still have lumps and it wasn't fixable.Fda safety report id # (b)(4).

• Brand Name: J PLASMA RENUVION
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): APYX MEDICAL CORPORATION
• MDR Report Key: 15894421
• MDR Text Key: 304727543
• Report Number: MW5113562
• 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: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• 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 Age: 36 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White