MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; CATHETER,FOLEY,100%SILICONE,12FR,10ML,LF

Catalog Number	DYND11500
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	04/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility, a rn went to remove a foley post op, the balloon was deflated and removed most of the way but then felt resistance at the very end as it was stuck.The rn was able to get the patient to relax, extra lubrication was applied, and the catheter was able to be removed.The patient experienced pain and discomfort during removal.There was no bleeding or tears to the penis noted.The catheter had a hard ridge where the catheter balloon had retracted into itself created a hard ridge.Post catheter removal, the patient was able to void without issue.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.
Event or Problem Description
According to the facility, a rn went to remove a foley post op, the balloon was deflated and removed most of the way but then felt resistance at the very end as it was stuck.

• Brand Name: MEDLINE
• Common Device Name: CATHETER,FOLEY,100%SILICONE,12FR,10ML,LF
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25210454
• Report Number: 1417592-2026-01468
• Device Sequence Number: 21450859
• Product Code: EZL
• UDI-Device Identifier: 10080196801220
• UDI-Public: 10080196801220
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K082815
• 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): 05/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: DYND11500
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 05/18/2026
• 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: Unknown