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

Model Number 9160F

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Event Description

A patient allegedly experienced a superficial with a 2nd degree left thigh burn during use of 3m¿ universal electrosurgical pads 9160f, lot 2025-04 eu.No medical interventions were reported.

Manufacturer Narrative

Patient information: not available.Initial reporters' occupation is unknown.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
• Type of Device: GROUNDING PAD
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M COMPANY VALLEY PLANT; 600 meigs st.; valley NE 68064
• Manufacturer Contact: dianne gibbs ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144 ; 6517379117
• MDR Report Key: 15798479
• MDR Text Key: 303657038
• Report Number: 2110898-2022-00117
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10707387462618
• UDI-Public: 10707387462618
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K974553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9160F
• Device Catalogue Number: 9160F
• Device Lot Number: 202504EU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other