MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; DBD-1LYR SILI-ELA LTX 16FR 10ML COUDE TR

Catalog Number	DYND160116C
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Unspecified Blood or Lymphatic problem (4434)
Date of Event	11/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility, on (b)(6) 2025, patient went to the emergency room a few hours after changing catheter and was experiencing "sudden new onset of penile pain." catheter balloon was believed to be in the urethra.The catheter was replaced and "patient had immediate relief upon change." the facility reports the patient had "worsening lab work, ongoing medical treatment, antibiotics." no additional information at this time.The product has been requested for evaluation.It has been determined that the reported event caused or contributed to a serious injury requiring medical intervention.This is a reportable event.If additional information becomes available this report will be reopened and reevaluated.
Event or Problem Description
According to the facility, on (b)(6) 2025, patient went to the emergency room a few hours after changing catheter and was experiencing "sudden new onset of penile pain." catheter balloon was believed to be in the urethra.

• Common Device Name: DBD-1LYR SILI-ELA LTX 16FR 10ML COUDE TR
• 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: 23782600
• Report Number: 1417592-2025-00710
• Device Sequence Number: 13297950
• Product Code: OHR
• UDI-Device Identifier: 10884389118757
• UDI-Public: 10884389118757
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/11/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYND160116C
• 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: 11/13/2025
• Initial Report FDA Received Date: 12/11/2025
• 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 Age: 87 YR
• Patient Sex: Male
• Patient Weight: 90 KG