MAUDE Adverse Event Report: 3M COMPANY 3M ELECTROSURGICAL PATIENT GROUNDING PAD; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 8149F

Device Problems Grounding Malfunction (1271); Protective Measures Problem (3015)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 11/08/2022

Event Type  malfunction  

Event Description

After a radio-frequency procedure was complete, the grounding pad was removed from the pt's right thoracic area.Pea sized burn was assessed at the left upper corner of the grounding pad site and 1/2 x 1/4 inch burn at the right lower corner of the grounding pad site.

• Brand Name: 3M ELECTROSURGICAL PATIENT GROUNDING PAD
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): 3M COMPANY
• MDR Report Key: 15864816
• MDR Text Key: 304353479
• Report Number: MW5113461
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2024
• Device Catalogue Number: 8149F
• Device Lot Number: "202401B8"
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White