MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; TTL1LYR 16FR10ML SILVER UM TR

Catalog Number	URO170516
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the facility the foley catheter "develops crust at the meatus and plugs off easily requiring an er visit for catheter irrigation and change".
Additional Manufacturer Narrative
Per the facility the foley catheter "develops crust at the meatus and plugs off easily requiring an er visit for catheter irrigation and change".No additional information is available at this time.The sample was requested for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
Updated: b4, d2a, d2b, d3, d4, g4, g6, h2, h4.

• Common Device Name: TTL1LYR 16FR10ML SILVER UM TR
• 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: 18170116
• Report Number: 1417592-2023-00456
• Device Sequence Number: 7625697
• Product Code: OHR
• UDI-Device Identifier: 40889942126768
• UDI-Public: 40889942126768
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 10/16/2025

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 Expiration Date: 11/30/2024
• Device Catalogue Number: URO170516
• Device Lot Number: 23HBD441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2023
• Supplement Date Received by Manufacturer: 09/21/2025
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2023
• 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: Unknown