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	Partial thickness (Second Degree) Burn (2694)
Date of Event	12/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial report was received from distributor.Additional information was received from the patient (1feb2018, 7feb2018) and from the facility (6feb2018).Actual device used in this report was not received.Seventeen samples from the same lot number were received, tested and met specifications.End of report.
Event or Problem Description
A patient allegedly had a 9130 3m universal electrosurgical pad applied to her right buttocks prior to a radiofrequency back ablation procedure.During the procedure, the patient reported burning and pain on her right side.At the end of the procedure, the plate was removed and a burn was discovered.The patient allegedly experienced two second degree burns.One crescent shaped burn, approximately 1 ½" - 2 " long was located at the top portion of the electrosurgical pad.There was a second burn, located in the middle of the pad placement, about the size of a quarter.The patient was seen in a wound clinic two weeks after the event occurred.The areas were cleaned and scraped weekly.An antibiotic gel and daily dressing changes were used to treat the sites.The sites are now closed and healed but itching, scarring and discoloration remain at the sites.She also reported periodic discomfort when sitting.

• 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: 7272042
• Report Number: 2110898-2018-00018
• Device Sequence Number: 11197947
• Product Code: GEI
• UDI-Device Identifier: 50707387462562
• UDI-Public: 50707387462562
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K974553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,user fac
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/14/2018

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: 02/28/2020
• Device Model Number: N/A
• Device Catalogue Number: 9130
• Device Lot Number: 2020-02-CK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2018
• Initial Report FDA Received Date: 02/14/2018
• 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: Required Intervention
• Patient Age: 57 YR