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	Nervous System Injury (2689)
Date of Event	11/30/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Information was not provided.Product lot number was not provided.Without a lot number, manufacturer date and expiration date cannot be determined.Patients having perineal procedures are often placed in the lithotomy position, using stirrups.Positioning, such as prolonged stretching or compression of nerves may also be associated with postoperative numbness and may result in permanent loss of sensation.Sufficient information, such as patient positioning, placement of electrosurgical pad, length of surgery etc.Was not provided to complete a full investigation of reported event.End of report.
Event or Problem Description
A urologist in denmark reported a 9160 3m¿ universal electrosurgical pad was applied to a patient's thigh for use of an electric knife (diathermia) during a perineal surgical procedure.The urologist alleged the patient felt reduced sensation exactly where the electrosurgical pad was applied following the procedure.The urologist alleged, the patient continues to have decreased sensation in that specific location, one year following the surgery.

• 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: 8465891
• Report Number: 2110898-2019-00044
• Device Sequence Number: 18881454
• Product Code: GEI
• UDI-Device Identifier: 00850794007163
• UDI-Public: 00850794007163
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K974553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/29/2019

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 Model Number: N/A
• Device Catalogue Number: 9160
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2019
• Initial Report FDA Received Date: 03/29/2019
• 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: Disability