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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	05/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Race: information not provided.Initial reporter's occupation not provided.The product sample was not returned for evaluation.A dhr (device history review) was completed for the reported product lot #.The dhr did not indicate any quality issues with the reported lot #.The customer reported the patient plate was placed in the "dorsal thoracic region between the left scapula and the spine" during a cardiac ablation procedure in which the patient was in a "horizontal dorsal decubitus" position.This would indicate that the plate was placed on the patient's back and the patient was lying on top of the plate.If this was the case, it is possible the plate was overloaded with too much current due to the placement of the plate and had excess weight on the plate.The instructions for use state: "do not place the universal pad under the patient.Weight bearing sites have restricted blood flow and may reduce the performance of the universal pad." the instructions for use also state "avoid placement over bony prominences, metal prostheses, or scar tissue." closely following the instructions for use reduces the risk of burns and pressure necroses.It was not possible to definitively establish causality of the reported injury.3m will continue to monitor.
Event or Problem Description
A hospital employee alleged that a (b)(6)-year-old female patient, weighing (b)(6) kg, underwent a radiofrequency cardiac ablation procedure on (b)(6) 2019.The surgery was 2 hours in length.The patient was in a horizontal dorsal decubitus position during the procedure.The patient had a 3m electrosurgical plate (model 9165) placed on the left interscapular region.No skin preparation was performed.An insite c3 navx rf generator was used.During the removal of the scalpel plate, in the dorsal thoracic region between the left scapula and the spine, a skin lesion was noted.The injury was described as skin cauterization/burn.No patient skin sensitives/allergies were specified.The wound was reportedly located under the plate's edge region.The plate was removed without difficulty.The plate was reportedly fully adhered when removed.The patient was discharged the day after the procedure.The wound was reportedly treated daily, at home by the patient's family, using papain dressings.The nurse reported the patient was doing well with the clinical treatment at home.
Additional Manufacturer Narrative
Event or Problem Description
A hospital employee alleged that a (b)(6) female patient, weighing (b)(6), underwent a radiofrequency cardiac ablation procedure on (b)(6) 2019.The surgery was 2 hours in length.The patient was in a horizontal dorsal decubitus position during the procedure.The patient had a 3m electrosurgical plate (model 9165) placed on the left interscapular region.No skin preparation was performed.An insite c3 navx rf generator was used.During the removal of the scalpel plate, in the dorsal thoracic region between the left scapula and the spine, a skin lesion was noted.The injury was described as skin cauterization/burn.No patient skin sensitives/allergies were specified.The wound was reportedly located under the plate's edge region.The plate was removed without difficulty.The plate was reportedly fully adhered when removed.The patient was discharged the day after the procedure.The wound was reportedly treated daily, at home by the patient's family, using papain dressings.The nurse reported the patient was doing well with the clinical treatment at home.

• 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: 8965329
• Report Number: 2110898-2019-00101
• Device Sequence Number: 16666166
• Product Code: GEI
• UDI-Device Identifier: 50707387462593
• UDI-Public: 50707387462593
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K974279
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2019

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: 09/09/2021
• Device Model Number: N/A
• Device Catalogue Number: 9165
• Device Lot Number: 2021-09 LN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2019
• Supplement Date Received by Manufacturer: 07/02/2019
• Initial Report FDA Received Date: 09/05/2019
• Supplement Report FDA Received Date: 09/05/2019
• 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
• Patient Age: 70 YR
• Patient Weight: 68