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

Model Number	9130
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	02/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is available for return and the device evaluation is anticipated.3m will continue to monitor.The instructions for use states, to reduce the risk of burns the site must be clean, dry and free of hair and to remove hair at application site.
Event or Problem Description
A patient underwent a left lower leg calf debridement with the use of the 3m¿ universal electrosurgical pad, 9130.Upon postoperative removal of the pad, a 3 cm x 2 cm third-degree burn extending to approximately 10 cm circumference was observed.The total time of the monopolar electrocautery use was approximately 2-30 minutes.
Additional Manufacturer Narrative
A sample was returned and confirmed there was damage to the device.Due to contamination, no additional testing can be performed on the device.Retained samples were visually inspected and no signs of defects were observed.A device history review of lot 202411oh exhibited no abnormal results, and all release testing met specification.Solventum will continue to monitor.
Additional Manufacturer Narrative
Initial mdr 2110898-2024-00013 noted the following: section g3 date received by manufacturer: 02/16/2024.Correction: section g3 date received by manufacturer: 02/22/2024.

• Brand Name: 3M¿ UNIVERSAL ELECTROSURGICAL PAD
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): 3M COMPANY; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M COMPANY VALLEY PLANT; 600 east meigs st.; valley NE 68064
• Manufacturer Contact: nadia battah ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144 ; 6514612670
• MDR Report Key: 18914712
• Report Number: 2110898-2024-00013
• Device Sequence Number: 17899077
• Product Code: GEI
• UDI-Device Identifier: 50707387462562
• UDI-Public: 50707387462562
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K974553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/15/2024
• Device Model Number: 9130
• Device Catalogue Number: 9130
• Device Lot Number: 202411OH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2024
• Supplement Date Received by Manufacturer: 04/26/2024; 02/22/2024
• Initial Report FDA Received Date: 03/15/2024
• Supplement Report FDA Received Date: 05/17/2024; 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown