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	03/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was not returned to 3m for analysis.A device history review was conducted on 1149c-lp, lot: 2022-01ac and the record showed no quality issues with this lot.Concomitant medical products used were: valleylab force fx (tm) electrosurgical generator, medline cautery pencil, push-button stainless-steel blade.End of report.
Event or Problem Description
A registered nurse (rn) reported that a 3m¿ universal electrosurgical pad (1149c-lp) was applied to a patient's right anterior/lateral thigh during a bodytite abdominal and facetite face and neck surgical procedures with bilateral excision of axilla dogears.The patient was in supine position during the procedure.The rn informed that toward end of procedure, a cautery pencil, push-button stainless-steel blade, stopped working, and after the electrocautery pencil was replaced, the grounding plate was checked and the burn was identified at that time.The rn alleged that a 2cm x 2cm 3rd degree thermal burn occurred under the cautery grounding pad.Treatment consisted of primary excision and closure.The patient is reported to be healing well.

• 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: 8633808
• Report Number: 2110898-2019-00074
• Device Sequence Number: 2353801
• Product Code: GEI
• UDI-Device Identifier: 50707387580716
• UDI-Public: 50707387580716
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/22/2019

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: 01/02/2022
• Device Model Number: N/A
• Device Catalogue Number: 1149C-LP
• Device Lot Number: 2022-01 AC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2019
• Initial Report FDA Received Date: 05/22/2019
• 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: VALLEYLAB FORCE FX GEN.MEDLINE CAUTERY PENCIL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Weight: 88