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	Superficial (First Degree) Burn (2685)
Date of Event	01/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: generator: electrobistiri ahanvos maodelo hb300a serie a1404001.The injury was reported as a first-degree burn but due to the nature of the treatment (enzymatic debridement), an mdr was submitted for this reported event.The report noted the patient was repositioned during surgery and when the universal pad was removed, it was found to be only partially adhered.The instructions for use note the following information under warnings, #4 pad application, to reduce the risk of burns and pressure necroses: do not reposition universal pad after initial application.If patient is repositioned, confirm full pad to pad skin contact and integrity of all connections.
Event or Problem Description
A hospital employee alleged a 9130 3m universal electrosurgical pad was placed on a patient's posterior right upper arm prior to a 6- hour surgical procedure.The patient was reportedly repositioned from supine to prone during the surgery.The electrosurgical pad was partially adhered prior to removal and the patient allegedly experienced a 3.0 cm x 1.0 cm 1st degree skin burn under the ground pad site.The injury required debridement with iruxol (enzymatic debridement) and was washed with saline.Cuticell and melolin dressings were applied to the site.The injury was reportedly healing.

• 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: 7323287
• Report Number: 2110898-2018-00021
• Device Sequence Number: 18859572
• Product Code: GEI
• UDI-Device Identifier: 50707387462562
• UDI-Public: 50707387462562
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 03/07/2018

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: 11/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 9130
• Device Lot Number: 2019-11-0G
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2018
• Initial Report FDA Received Date: 03/08/2018
• 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: ACTIVE ELECTRODE: HUATONG; ELECTROBISTIRI AHANVOS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 32 YR
• Patient Weight: 66