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

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

Patient Problems Itching Sensation (1943); Muscle Weakness (1967); Skin Discoloration (2074); Numbness (2415); Alteration in Body Temperature (4568)

Event Date 05/07/2022

Event Type  Injury  

Event Description

I-plasma used post-liposuction for skin tightening.My torso felt hot to the touch for 2 months.I had zero core strength and required a home nurse for 7 weeks.Still have splotchy skin discoloration, incessant itching, and numbness.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: 15499236
• MDR Text Key: 300884445
• Report Number: MW5112313
• 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: 09/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2022
• 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
• Treatment: ADVIL DAILY FOR PAIN ; CYMBALTA; TRAZODONE ; WELLBUTRIN ; XANAX
• Patient Outcome(s): Other; Disability
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White