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

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	07/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No sample has been received to date.Results: reporter stated he was sending the patient plate for analysis.The sample has not been received to date.3m completed a device history review (dhr) and no issues were identified.In addition, (b)(4) retained samples were inspected and no issues were identified.
Event or Problem Description
A surgeon reported a 9135-lp 3m¿ universal electrosurgical pad was applied to a female patient's left anterior lateral thigh prior to a lipo abdominoplasty.Following the surgery, the electrosurgical pad was removed and a full thickness (3rd degree) burn wound was discovered on the patient's lower, left lateral thigh.The burn wound was excised and a primary closure was completed.The patient was healing well one week following the event.
Additional Manufacturer Narrative
Reporter address was corrected.Method - in addition to method 10 and 3331, retained samples from the same lot were also inspected and no defect was found.All indications show the 3m¿ electrosurgical patient plate in question met all product specifications with no defects.End of report.

• 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: 7719511
• Report Number: 2110898-2018-00078
• Device Sequence Number: 16420877
• Product Code: GEI
• UDI-Device Identifier: 50707387580730
• UDI-Public: 50707387580730
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K974279
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2018

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: 12/15/2020
• Device Model Number: N/A
• Device Catalogue Number: 9135-LP
• Device Lot Number: 2020-12 PO
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2018
• Initial Date Received by Manufacturer: 07/06/2018
• Supplement Date Received by Manufacturer: 07/06/2018
• Initial Report FDA Received Date: 07/25/2018
• Supplement Report FDA Received Date: 08/23/2018
• 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: ARRON MEDICAL BOVIE HANDPIECE; VALLEY LAB FORCE 2 GENERATOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 30 YR
• Patient Weight: 82