MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; 1LYRTR 16FR10ML LATEX DB SNAP

Catalog Number	URO175116
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Failure of foley catheter balloon.
Additional Manufacturer Narrative
It was reported that the device was in place during "infrared therapy" and had been in place "longer than four weeks" when the balloon "failed".It was reported that the balloon keeps "breaking".No additional information was provided.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.

• Common Device Name: 1LYRTR 16FR10ML LATEX DB SNAP
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 22300625
• Report Number: 1417592-2025-00304
• Device Sequence Number: 9244516
• Product Code: OHR
• UDI-Device Identifier: 10193489987294
• UDI-Public: 10193489987294
• 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): 06/20/2025

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: URO175116
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 06/20/2025
• 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