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

Catalog Number	DYND160116C
Medical Device Problem Codes	Fluid/Blood Leak (1250); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Genital Bleeding (4507); Swelling/ Edema (4577); High White Blood Cell Count (4594)
Date of Event	10/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility, a foley catheter was inserted "without issue," and within a few days, the patient was complaining of "penile pain" and lab work showed "increased white blood cell count without known cause." a ct was performed and the "balloon was noted to be in the prostate." the catheter was changed and "noted to have less fluid than what was instilled upon insertion." per the facility, this caused "worsening lab work, swelling of the prostate, bleeding, ongoing medical treatment, antibiotics." patient has now "clinically improved." the product is not available for evaluation.No additional information at this time.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, therefore, 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 foley catheter was inserted "without issue," and within a few days, the patient was complaining of "penile pain" and lab work showed "increased white blood cell count without known cause." a ct was performed and the "balloon was noted to be in the prostate.".

• 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: 23729918
• Report Number: 1417592-2025-00684
• Device Sequence Number: 15874977
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/05/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 12/05/2025
• 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
• Patient Weight: 72 KG