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

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Burn(s) (1757)

Event Date 09/12/2022

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 300995443
• Report Number: 2110898-2022-00091
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 50707387563504
• UDI-Public: 50707387563504
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K833364
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 09/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2021
• 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
• Treatment: HORMONE TREATMENTS (TYPE UNKNOWN)
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Sex: Female