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	Full thickness (Third Degree) Burn (2696)
Date of Event	07/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient: not available ethnicity: not available.Race: not available.Establishment name, address, city, state, zip and telephone number not available.Device is not available for evaluation.Without a sample available, it is not possible to evaluate the sample for any defects or perform any tests to determine if the plate met specification.Without additional information, it is not possible to determine the exact root cause of the alleged injury or whether a patient plate was the root cause.Total activation time of the electrode is unknown.As stated in the instructions for use (ifu) provided, the universal pad should not be overloaded with too much current to reduce the risk of burns.It is possible that if the active electrode was activated too long or higher power setting than necessary was used that this could overload the pad with too much current and result in a patient burn.
Event or Problem Description
A physician reported a (b)(6)-year-old female patient, weighing (b)(6) lbs was undergoing a breast augmentation on (b)(6) 2020 and alleged a 3rd degree full thickness burn from 3m¿ universal electrosurgical pad 9165.The patient was positioned supine for a one-hour surgery and grounded on the left thigh.The burn was reported to be 9 x 2.5 cm.Force fx¿ electrosurgical generator cut and coagulation settings were 50; total activation time of the active electrode is unknown.There was no alarm during the surgery.Upon removal; the plate was completely adhered to the patient and there was no difficulty noted on removal.Medical history includes no known allergies or skin sensitivities.Approximately two weeks after injury the surgeon performed a direct excision of the burn.Currently patient is healing from the excision.No further information is available.

• Brand Name: 3M UNIVERSAL ELECTROSURGICAL PAD
• Common Device Name: GROUNDING PAD
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul, mn
• MDR Report Key: 10431974
• Report Number: 2110898-2020-00045
• Device Sequence Number: 1875040
• Product Code: GEI
• UDI-Device Identifier: 50707387462593
• UDI-Public: 50707387462593
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/20/2020

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: 10/23/2022
• Device Model Number: N/A
• Device Catalogue Number: 9165
• Device Lot Number: 202210NJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 08/20/2020
• 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
• Patient Age: 25 YR
• Patient Weight: 45