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 Codes	Erythema (1840); Superficial (First Degree) Burn (2685)
Date of Event	06/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier, ethnicity, race: information was not provided.A photo of the reported injury was provided which appeared to reflect skin redness in the area under the patient plate border adhesive.A device history review of product lot # showed no quality issues.Without a sample provided for evaluation root cause of the reported injury could not be established.
Event or Problem Description
A hospital in (b)(6) reported a (b)(6)-year-old male patient, weighing (b)(6)kg, was hospitalized for ventricular tachycardia ablation on (b)(6) 2019.The surgery was 230 minutes in length.The patient was placed in a supine position during the procedure.A 9130 3m¿ universal electrosurgical plate was placed on the patient's back.No skin preparation was conducted at the plate site.The patient reportedly showered and applied betadine the day and evening prior to surgery.A medium level of body hair was reportedly present at the plate site.An ep shuttle storage generator was used.The plate was reportedly lightly adhered when removed at the end of the procedure.Upon removal, the patient allegedly had redness and a 1st degree burn on the middle of his back.No patient skin sensitives/allergies were specified.The wound was reportedly located under the plate and equal to the size of the plate.The wound was treated with lamiderm° and large compresses.The patient was reportedly in good health at the end of hospitalization.

• 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: 8956098
• Report Number: 2110898-2019-00098
• Device Sequence Number: 16666105
• Product Code: GEI
• UDI-Device Identifier: 50707387462562
• UDI-Public: 50707387462562
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/03/2019

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 Expiration Date: 05/23/2021
• Device Model Number: N/A
• Device Catalogue Number: 9130
• Device Lot Number: 2021-05 FZ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2019
• Initial Report FDA Received Date: 09/03/2019
• 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: Other; Required Intervention
• Patient Age: 49 YR
• Patient Weight: 90