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

Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	10/25/1990
Type of Reportable Event	Serious Injury
Event or Problem Description
Dr.(b)(6) injured me with the j-plasma and vaser after denying any side effects.Fda safety report id #(b)(4).

• Brand Name: J-PLASMA
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): APYX MEDICAL CORPORATION
• MDR Report Key: 15825699
• Report Number: MW5113360
• Device Sequence Number: 18863958
• Product Code: QPB
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 11/15/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/17/2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability; Required Intervention
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian