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	08/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Information not provided.Reporter address not provided.Reporter occupation not provided.The 3m analysis suggested that this adverse event may be associated with skin stripping.However, we are filing this adverse event as a burn based on the information reported by the hospital.End of report.
Event or Problem Description
A hospital employee in (b)(6) reported a 9165 3m¿ universal electrosurgical patient plate was applied to a patient's right calf during a pericardial window procedure.The patient allegedly experienced a burn on the right calf, slightly larger than a fifty-cent coin.Skin was reportedly peeled from the burn area when the patient plate was removed.Fucidin cream was reportedly used for treatment.

• 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: 7890619
• Report Number: 2110898-2018-00086
• Device Sequence Number: 13892732
• Product Code: GEI
• UDI-Device Identifier: 50707387462593
• UDI-Public: 50707387462593
• Combination Product (Y/N): N
• Initial Reporter Country: BX
• 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): 09/19/2018

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: 11/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 9165
• Device Lot Number: 2020-11 OO
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 09/19/2018
• 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: VALLEY LAB FORCE 2 GENERATOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 54