MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ UNIVERSAL ELECTROSURGICAL PADS; GROUNDING PAD

Model Number	9160F
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A child allegedly experienced 1st and 2nd degree burns with blistering on the inner aspect of the left calf and hyperemia on the right calf with the use of the 3m¿ universal electrosurgical pads 9160f, lot 202404ep.Silver sulfadiazine and gauze were applied.The patient had reportedly underwent an emergency appendectomy with the use of an electric scalpel.
Additional Manufacturer Narrative
Reporter: anonymous.It is unknown if the reporter was a health professional.Product sample was not returned to 3m for analysis.Without a sample available, it is not possible to evaluate the sample for any defects or perform any tests to determine if the plate met specification.3m¿ cannot determine the exact root cause of the alleged injury or whether a patient plate was the root cause.To reduce the risk of burns, all instructions should be followed as per the instructions for use (ifu).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.3m¿ will continue to monitor.

• Brand Name: 3M¿ UNIVERSAL ELECTROSURGICAL PADS
• Common Device Name: GROUNDING PAD
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144 1000
• Manufacturer (Section G): 3M COMPANY VALLEY PLANT; 600 meigs st.; valley NE 68064
• Manufacturer Contact: nadia battah ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144-1000 ; 6514612670
• MDR Report Key: 16547687
• Report Number: 2110898-2023-00027
• Device Sequence Number: 5946581
• Product Code: GEI
• UDI-Device Identifier: 10707387462618
• UDI-Public: 10707387462618
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K974553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/15/2023

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: 04/24/2025
• Device Model Number: 9160F
• Device Catalogue Number: 9160F
• Device Lot Number: 2025-04-EP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 03/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2022
• 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: Required Intervention
• Patient Sex: Unknown