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

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	01/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The alleged burn did not occur under the patient plate.With the information provided, 3m was unable to determine the potential cause of the alternate site burn.
Event or Problem Description
A hospital employee reported that a patient experienced a second degree burn (size; 4% of forearm) and blistering on her right forearm during a four hour unspecified type of debridement surgery.A 3m universal electrosurgical pad was allegedly applied to her right upper arm.The burn and blistering did not occur under the electrosurgical pad placement.The patient allegedly required surgical debridement, minor tendon libation and a fasciotomy for treatment and was reportedly in good condition.

• Brand Name: 3M UNIVERSAL ELECTROSURGICAL PAD
• Common Device Name: ELECTROSURGICAL GROUNDING PLATE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 7231665
• Report Number: 2110898-2018-00016
• Device Sequence Number: 13796053
• Product Code: GEI
• UDI-Device Identifier: 50707387462593
• UDI-Public: 50707387462593
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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
• Report Date (Section B): 01/31/2018

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: 04/30/2017
• Device Model Number: N/A
• Device Catalogue Number: 9165
• Device Lot Number: 2020-04 EW
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2018
• Initial Report FDA Received Date: 01/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COVIDIEN FORCE FX GENERATOR; WARMING SYSTEM, TYPE AND MODEL UNSPECIFIED.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR