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

Catalog Number	DYND160116C
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Swelling/ Edema (4577)
Date of Event	11/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2025 within "a few days" after catheter insertion, the patient began complaining of "penile pain", and an ultrasound showed that the balloon "in the prostate".The customer reported the catheter was exchanged, and the balloon was noted to "have less fluid than what was instilled upon insertion".The customer reported that due to the reported incident the patient had "worsening lab work, swelling of prostate, bleeding, ongoing medical treatment, and antibiotics".No additional information is available at this time.It has been determined that the reported event caused or contributed to serious injury, 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 customer, on (b)(6) 2025 within "a few days" after catheter insertion, the patient began complaining of "penile pain", and an ultrasound showed that the balloon "in the prostate".

• Brand Name: MEDLINE
• Common Device Name: DBD-1LYR SILI-ELA LTX 16FR 10ML COUDE TR
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 23780210
• Report Number: 1417592-2025-00705
• Device Sequence Number: 10076064
• 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?: 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: 11/13/2025
• 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 Sex: Male
• Patient Weight: 72 KG