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

Catalog Number	DYND160116C
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Date of Event	11/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility on (b)(6) 2025, "he was complaining of penile pain and discomfort.Catheter was removed, only 9cc of the original 10cc was noted".It was stated that there was worsening lab work, swelling of prostate, and ongoing medical treatment such as antibiotics being given.The patient refused catheter replacement and still has sever penile pain which the patient is still being treated for.The device is not available 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, "he was complaining of penile pain and discomfort".

• Common Device Name: DBD-1LYR SILI-ELA LTX 16FR 10ML COUDE TR
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 23778718
• Report Number: 1417592-2025-00706
• Device Sequence Number: 10105462
• 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
• 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?: No
• Device Catalogue Number: DYND160116C
• Was Device Available for Evaluation?: No
• 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: 77 YR
• Patient Sex: Male
• Patient Weight: 104 KG