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	Injury (2348)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Retained samples from the same lot were tested and no quality issues were found.In addition, no trend was seen with a review of similar type complaints.The skin injury was likely the results of high mechanical forces when the electrosurgical plate was removed.If a patient has skin atrophy, there is often a reduced strength of the papillary junction between the dermis and the epidermis.This type of skin injury could occur if the patient plate was not removed carefully.The product ifu states the user should not remove the plate by pulling on the cable or cord.The user should start at a corner and peel back the plate slowly at a 180-degree angle to prevent skin trauma.End of report.
Event or Problem Description
A hospital employee alleged a patient experienced a "wound" when a 9160f 3m¿ universal electrosurgical pad was removed from the right thigh.The hospital employee alleged the patient's skin remained stuck to the pad when it was removed.

• 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: 8327192
• Report Number: 2110898-2019-00020
• Device Sequence Number: 10814650
• Product Code: GEI
• UDI-Device Identifier: 10707387462618
• UDI-Public: 10707387462618
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K974553
• 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): 02/11/2019

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: 07/28/2021
• Device Model Number: N/A
• Device Catalogue Number: 9160F
• Device Lot Number: 2021-07 JV
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2019
• Initial Report FDA Received Date: 02/11/2019
• 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: Other