MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; PAD, GROUNDING, UNIVERSAL, SOLID, 9'

Catalog Number	PAD9135-LP
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility on (b)(6) 2025 the staff member "applied the pad to patients' right thigh.After surgery about an inch size of skin burn was noticed where the grounding pad was applied and the attending began to treat it immediately".Per the facility the skin was clean, dry, and intact and it was not placed over metal or a tattoo.Per the facility the patient required "bacitracin and debridement of wound".No additional information is available.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
According to the facility on (b)(6) 2025 the staff member "applied the pad to patients' right thigh.After surgery about an inch size of skin burn was noticed where the grounding pad was applied and the attending began to treat it immediately".

• Common Device Name: PAD, GROUNDING, UNIVERSAL, SOLID, 9'
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 22554768
• Report Number: 1417592-2025-00343
• Device Sequence Number: 9576507
• Product Code: GEI
• UDI-Device Identifier: 10193489082500
• UDI-Public: 10193489082500
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 07/21/2025

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
• Device Catalogue Number: PAD9135-LP
• Device Lot Number: 1037124110009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2024
• 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: 38 YR
• Patient Sex: Female
• Patient Weight: 93 KG