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

Model Number 8149F

Patient Problem Erythema (1840)

Event Date 08/05/2022

Event Type  malfunction  

Event Description

Registered nurse (rn) placed cautery pad on patient's left thigh on clean, intact, dry skin without tattoo or metal implants.After the case, rn removed cautery pad.In phase two, a red raised patch with blisters is noted.There is also a dime sized piece of discolored tissue.Same rn was called to assess.Rn contacted the operating room (or) charge nurse.Surgeon was called to assess.Pictures were taken.The pad was not saved because the red area was not present at the time the pad was removed.It appeared later according to the circulators.They put silvadene cream and a gauze on the area.The patient was instructed to follow up with his primary care physician (pcp), and surgeon would follow up with him at his next appointment.

• Brand Name: 3M
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): 3M COMPANY; 3m center, 2510 conway ave; bldg. 275-5w-06; saint paul MN 55144
• MDR Report Key: 17956694
• MDR Text Key: 325925063
• Report Number: 17956694
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/20/2023,12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8149F
• Device Catalogue Number: 8149F
• Device Lot Number: 202310NP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/20/2023
• Event Location: Hospital
• Date Report to Manufacturer: 10/18/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/18/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 22630 DA
• Patient Sex: Male
• Patient Race: White