MAUDE Adverse Event Report: UNKNOWN PRO PLASMA ESTHETICS JET PLASMA PEN; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Device Problem Sparking (2595)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 12/28/2022

Event Type  Injury  

Event Description

Sparks fly from the sides of the device and cause burns.

• Brand Name: PRO PLASMA ESTHETICS JET PLASMA PEN
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 16086087
• MDR Text Key: 306658868
• Report Number: MW5114132
• 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: Nurse
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White