MAUDE Adverse Event Report: ARGENTUM MEDICAL, LLC MEN'S LIBERTY; EXTERNAL CATHETER

Model Number	23046
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the 1st (to date) safety complaint for this lot.Manufacturing records for this lot were reviewed, and there were no discrepancies noted.There were no nonconformances associated with this lot.Doctor's notes were not received but a review of the patient history notes provided during initial account setup was conducted.Patient history notes showed multiple urinary and incontinence issues.The patient's medical history of incontinence, his medication, or urine leaks could have contributed to the infection, but the cause of this report is unclear.There is no indication that the device failed to meet specifications or malfunctioned.Complaint will be updated if more information is provided by the patient or doctor's notes confirming infection are received.There is no confirmed history of infection related to our product.As a show of an abundance of caution, the complaint is being reported.
Event or Problem Description
Patient was contacted for 30-day follow up.Patient stated he is not using ml anymore as he experienced a uti that was treated in the hospital.He stated he was not sure what caused it but has several health ailments and takes medication that can cause utis.Patient stated he is not using ml again until he consults with his urologist.Patient provided ml lot # k29507.Product specialist later reached out to the patient to get the name of the hospital to request doctor's notes on patient medical history and confirmation of infection but was unsuccessful.Patient was a first-time user and had previous calls with a product specialist about leaking possibly due to backflow, and the product specialist advised him to be mindful of positioning to prevent backflow.

• Brand Name: MEN'S LIBERTY
• Common Device Name: EXTERNAL CATHETER
• Manufacturer (Section D): ARGENTUM MEDICAL, LLC; 2571 kaneville ct.; geneva IL 60134
• Manufacturer Contact: julie schillo ; 2571 kaneville ct; geneva, IL 60134 ; 7274162685
• MDR Report Key: 21721142
• Report Number: 3001949129-2025-00002
• Device Sequence Number: 3993647
• Product Code: NOA
• UDI-Device Identifier: 00653599000168
• UDI-Public: (01)00653599000168(10)K29507(17)270331
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/28/2025

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
• Operator of Device: Lay User/Patient
• Device Model Number: 23046
• Device Lot Number: K29507
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/21/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Male