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

Catalog Number	9165
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	08/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A hospital reported a male 71-year-old patient experienced a 12cm x 7cm skin tear on the left calf upon removing 3m¿ 9165 universal electrosurgical pad.After a ten-minute polypectomy the pad was removed, and a skin tear was alleged.Skin was removed from the pad and applied to the skin tear with use of staples.Skin was not prepped prior to application and reported there was no difficulty removing the pad.
Additional Manufacturer Narrative
Device is not available for evaluation.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 at application site.The ifu also states to avoid placement over surgical prep solutions containing iodine.3m¿ will continue to monitor.

• Brand Name: 3M¿ UNIVERSAL ELECTROSURGICAL PAD
• Common Device Name: GROUNDING PAD
• Manufacturer (Section D): 3M HEALH CARE; 2510 conway avenue; st. paul MN 55144
• Manufacturer (Section G): 3M COMPANY VALLEY PLANT; 600 east 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: 15439902
• Report Number: 2110898-2022-00079
• Device Sequence Number: 12255580
• Product Code: GEI
• UDI-Device Identifier: 50707387523973
• UDI-Public: 50707387523973
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/16/2022

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: 06/10/2025
• Device Catalogue Number: 9165
• Device Lot Number: 202506GS
• 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: 08/23/2022
• Initial Report FDA Received Date: 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2022
• 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; Disability
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 59 KG
• Patient Race: White