MAUDE Adverse Event Report: 3M COMPANY VALLEY PLANT 3M¿ UNIVERSAL ELECTROSURGICAL PAD; ELECTROSURGICAL RETURN ELECTRODE

Catalog Number	9135-LP
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Codes	Necrosis (1971); Full thickness (Third Degree) Burn (2696)
Date of Event	11/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1 & a2: date of birth: not provided.H10: an investigation into this lot was performed and no quality issues were identified.At this time, a product sample has not been returned to 3m for analysis and a root cause is not able to be definitively determined.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 allegedly experienced a left thigh/hip 3rd degree burn with the use of the 3m¿ universal electrosurgical pads, 9135-lp lot 202503co.The physician observed a strong burning odor reportedly noted to be coming from the area of the grounding pad in less than one minute from the start of the case, and the physician stopped the case.The pad was noted to have a large burn mark through it and onto the patient's skin leaving a 3cm long x 1cm width left thigh/hip third degree burn with necrotic tissue that was only present through the burnt area on the 3m pad.The grounding pad was removed, and a second grounding pad was placed on the patient on the opposite of the first location and the case was continued.An intensivist and wound center were consulted, and the patient was referred to the emergency room.The patient was seen the next day for wound care follow up with subsequent follow ups.The patient is currently doing "okay".
Additional Manufacturer Narrative
H10 correction: h6 has been updated to code:3331, as it was not previously provided in the initial mdr.Submitted on 11/15/2023.3m received product samples has been received although the sample size was not adequate in order to perform testing.

• Brand Name: 3M¿ UNIVERSAL ELECTROSURGICAL PAD
• Common Device Name: ELECTROSURGICAL RETURN ELECTRODE
• Manufacturer (Section D): 3M COMPANY VALLEY PLANT; 600 east meigs st.; valley NE 68064
• 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 55144-1000 ; 6514611000
• MDR Report Key: 18139802
• Report Number: 2110898-2023-00100
• Device Sequence Number: 20828678
• Product Code: GEI
• UDI-Device Identifier: 50707387580730
• UDI-Public: 50707387580730
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K974279
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2023

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: 03/02/2025
• Device Catalogue Number: 9135-LP
• Device Lot Number: 202503CO
• 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: 10/20/2023
• Supplement Date Received by Manufacturer: 11/17/2023
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 12/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/03/2022
• 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 Age: 71 YR
• Patient Sex: Male
• Patient Weight: 125 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White