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 and only (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 reoccurring history of urinary incontinence, incomplete bladder emptying, and uti after a cystoscopy.The patient's medical history of incontinence or the failed connection and urine leak could have contributed to the infection, but the cause of this report is unclear.Product specialist tried to follow up with the patient on (b)(6) 2025 but was unsuccessful.Complaint will be updated if more information is provided by the patient or doctor's notes confirming infection are received.There is no indication that the device failed to meet specifications or malfunctioned.There is no confirmed history of infection related to our product.As a show of an abundance of caution, the complaint is being reported.Complaint will be updated if more information is provided by the patient or doctor's notes confirming the infection are received.
Event or Problem Description
Patient called in reporting he doesn't like ml and wanted to return the remaining supplies.Patient was a first-time user and did not have a documented product walkthrough with a product specialist, as the product specialist noted he declined a walkthrough and said he would call back if he wanted the walkthrough ((b)(6) 2025).He stated the second time he tried ml, he had a tremendous leak in the middle of the night.He stated the connection between ml and the bed bag failed which caused the leak.He stated he got a uti later that day with blood in his urine.Patient stated he was admitted to the hospital with a uti.Product specialist tried to ask about application, but he was firm on stopping use of ml and declined any type of troubleshooting or further questions.Patient stated he could not locate the lot #.Per his only sales order on record, it consisted of ml lot # 2025-0131.Product specialist 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.

• 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: 21619526
• Report Number: 3001949129-2025-00001
• Device Sequence Number: 15160408
• Product Code: NOA
• UDI-Device Identifier: 00653599000168
• UDI-Public: (01)00653599000168(10)2025-0131(17)270331
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 03/14/2025

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: 2025-0131
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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