MAUDE Adverse Event Report: COMEPA INDUSTRIES LIMITED ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Patient Problems Burning Sensation (2146); Superficial (First Degree) Burn (2685)

Event Date 12/11/2023

Event Type  Injury  

Event Description

During flutters, patients feeling a sensation of heat at the return plate and a small burn on the patient at the return plate.Procedure: atrial flutter.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COMEPA INDUSTRIES LIMITED; 21/f on hing building, on hing terrace, central hong kong; hong kong 00000 0; CH 000000
• MDR Report Key: 18419161
• MDR Text Key: 331713105
• Report Number: MW5149667
• 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: Unknown
• Type of Report: Initial
• Report Date: 12/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1