MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; CATHETER,FOLEY,TEMP SENS,12FR 10ML,LF

Catalog Number	DYND110512
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	11/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility on 11/29/23 "registered nurse attempted to remove foley (catheter) but noted resistance with about one inch of the catheter still in the urethra".
Additional Manufacturer Narrative
According to the facility on 11/29/23 "registered nurse attempted to remove foley (catheter) but noted resistance with about one inch of the catheter still in the urethra".Per the facility "morphine had to be administered due to the pain".Per facility "balloon noted to be folded on itself creating a ridge".No additional information is available.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, d4, g3, g6, h2.

• Common Device Name: CATHETER,FOLEY,TEMP SENS,12FR 10ML,LF
• 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: 18419465
• Report Number: 1417592-2023-00528
• Device Sequence Number: 12729501
• Product Code: EZL
• UDI-Device Identifier: 10884389123010
• UDI-Public: 10884389123010
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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 Catalogue Number: DYND110512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2023
• Supplement Date Received by Manufacturer: 09/21/2025
• Initial Report FDA Received Date: 12/29/2023
• Supplement Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown