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	05/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product sample was destroyed by the customer, therefore not available for evaluation.A dhr (device history review) was completed for the reported product lot #.The dhr did not show any quality issues during production of this lot.3m will continue to monitor.End of report.
Event or Problem Description
A (b)(6) year-old hispanic female patient, weighing (b)(6) kgs, reportedly had two 9165 3m¿ universal electrosurgical plates applied prior to an open reduction procedure of the proximal humeral on (b)(6) 2019.No skin preparation was conducted prior to application.The surgery was approximately 2 hours in length.The patient was initially in a supine position and then repositioned to a semi-fowler position during the surgery.At the end of the procedure, each plate was reportedly fully adhered and removed slowly.The patient was noted in her room, post-op, as having erythema and a second degree burn, approximately 50cm in size, with blisters.The injury was reportedly located in the dorsal, left lumbar region and left gluteus.The injuries were reported to not be under the plates.The patient had no history of skin sensitivities.The patient was treated by a physician and underwent burn wound healing and ambulatory care every 48 hours.The patient's current condition was reported as stable.No further information was provided.

• 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: 8873967
• Report Number: 2110898-2019-00092
• Device Sequence Number: 2742689
• Product Code: GEI
• UDI-Device Identifier: 50707387462593
• UDI-Public: 50707387462593
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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
• Type of Report: Initial
• Report Date (Section B): 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/14/2021
• Device Model Number: N/A
• Device Catalogue Number: 9165
• Device Lot Number: 2021-12 PN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 08/08/2019
• 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: WEM ELECTRONIC EQUIPMENT SS501S
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Weight: 68