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

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	06/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sample has not been received to date.Analysis is pending upon receipt of sample.3m is in the process of completing a device history review (dhr).
Event or Problem Description
A nurse reported a 9135-lp 3m¿ universal electrosurgical plate was applied to a female patient's right anterior thigh prior to breast revision surgery on (b)(6) 2019.No skin prep was conducted at the plate site prior to application.The application site was hair-free.Surgery length was not specified.The patient was placed in a supine position during surgery.The nurse reported all connections were checked and the pad connected with the patient's skin.Brand/ model of generator used was not specified.Total activation time of the active electrode was not provided.The active electrode was used intermittently for a minimal time during each use.The nurse reported the electrosurgical plate was gently removed by loosening the far corner of the pad.The plate was reported to be intact and adhered in total to the patient's leg upon removal.A 3rd degree burn wound, 2x4 centimeters in size, was discovered on the patient's skin at the junction where the cord enters the pad.Burns were also noticed on the cord.The burn wound was excised and a primary closure was completed.Silvadene cream and a tegaderm dressing was applied to the burn site, unspecified pain medication was provided, and a medicated bandage was applied.The patient visited the doctor for follow up on (b)(6) 2019.No further details were provided.
Additional Manufacturer Narrative
The product sample was returned and evaluated.The sample showed evidence of burn marks in the small rectangular area between the tab and the conductive gel.The sample was tested and was found that the plate was conducting properly.The evidence did not suggest that there was any malfunction of the plate itself that would have caused this type of injury.The evidence from this inspection did not substantiate the claim that the pad was fully adhered directly to the patient's skin.A photo provided of the alleged injury did not show evidence of where the patient plate was adhered to the patient's skin.The instructions for use state to ensure full pad-to-skin contact.A device history review was performed on the reported lot 2021-10nh.This device history review showed no manufacturing records that would indicate any quality issues with this lot.

• Brand Name: 3M UNIVERSAL ELECTROSURGICAL PAD
• Common Device Name: GROUNDING PAD
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 8776821
• Report Number: 2110898-2019-00086
• Device Sequence Number: 1845512
• Product Code: GEI
• UDI-Device Identifier: 50707387580730
• UDI-Public: 50707387580730
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K974279
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2019

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: 10/22/2021
• Device Model Number: N/A
• Device Catalogue Number: 9135-LP
• Device Lot Number: 2021-10 NH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2019
• Supplement Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 07/10/2019
• Supplement Report FDA Received Date: 09/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention