MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; PROTECTANT,SKIN,MARATHON,LIQUID

Catalog Number	MSC093001
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Separation Problem (4043); Premature Separation (4045)
Health Effect - Clinical Codes	Abrasion (1689); Skin Inflammation/ Irritation (4545)
Date of Event	09/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility, the marathon skin protectant was applied to an open area on an infant.When the nurse wiped the infant's buttocks, the marathon became detached, and the infant experienced further skin injury.No additional information at this time.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, the marathon skin protectant was applied to an open area on an infant.When the nurse wiped the infant's buttocks, the marathon became detached, and the infant experienced further skin injury.

• Common Device Name: PROTECTANT,SKIN,MARATHON,LIQUID
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; 3 lakes dr; northfield IL 60093
• Manufacturer Contact: alyssa reasner ; 3 lakes dr; northfield, IL 60093
• MDR Report Key: 23350549
• Report Number: 1417592-2025-00567
• Device Sequence Number: 7807107
• Product Code: KMF
• UDI-Device Identifier: 10884389109854
• UDI-Public: 10884389109854
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/21/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: MSC093001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Male