MAUDE Adverse Event Report: 3M HEALTH CARE MEDICAL SOLUTIONS DIVISION 3M¿ ELECTROSURGICAL PATIENT PLATES 8180F, UNCORDED, SPLIT GROUNDING PAD

Model Number	N/A
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	09/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A 41-year-old female allegedly experienced multiple burns on the right chest with the use of 3m¿ electrosurgical patient plates, non-corded, split grounding pad, 8180f, lot 2024-03 dd.The size of the burns was not identified.An outpatient clinician was consulted and performed a dressing change with no indication what type of treatment was provided.Medical history includes long term hormone treatment resulting in thin skin.The burns are reported to be healing.
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¿ ELECTROSURGICAL PATIENT PLATES 8180F, UNCORDED, SPLIT GROUNDING PAD
• Common Device Name: GROUNDING PAD
• Manufacturer (Section D): 3M HEALTH CARE MEDICAL SOLUTIONS DIVISION; 3m center, building 275-5w-06; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M HEALTH CARE MEDICAL SOLUTIONS DIVISION; 3m center, building 275-5w-06; 2510 conway ave; st. paul MN 55144
• Manufacturer Contact: dianne gibbs ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144 ; 6517379117
• MDR Report Key: 15523507
• Report Number: 2110898-2022-00091
• Device Sequence Number: 14121847
• Product Code: GEI
• UDI-Device Identifier: 50707387563504
• UDI-Public: 50707387563504
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K833364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2022

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: 03/16/2024
• Device Model Number: N/A
• Device Catalogue Number: 8180F
• Device Lot Number: 2024-03 DD
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2022
• Initial Report FDA Received Date: 10/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HORMONE TREATMENTS (TYPE UNKNOWN)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 41 YR
• Patient Sex: Female