MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; GROUNDING, UNIVERS, SPLIT, 15'CORD

Catalog Number	PAD9165L
Medical Device Problem Code	Grounding Malfunction (1271)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	07/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that a patient suffered a third degree burn to the right lateral thigh where a grounding pad was placed.The burn was discovered at the patient's two week post-op follow up.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that a patient suffered a third degree burn to the right lateral thigh where a grounding pad was placed.

• Common Device Name: GROUNDING, UNIVERS, SPLIT, 15'CORD
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes dr; northfield IL 60093
• Manufacturer Contact: gavin-ainsley nadong ; three lakes dr; northfield, IL 60093
• MDR Report Key: 22794851
• Report Number: 1417592-2025-00383
• Device Sequence Number: 8643500
• Product Code: GEI
• UDI-Device Identifier: 10193489082548
• UDI-Public: 10193489082548
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/13/2025

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 Catalogue Number: PAD9165L
• Device Lot Number: 27125030001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 98 KG