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

Model Number	23046
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Local Reaction (2035)
Date of Event	02/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Fda contacted us that a patient had submitted an adverse event report through their medwatch program (form mw5170048).Patient did not supply any personal information to contact them.Patient stated he started to experience sores and blisters on the tip of his anatomy where men's liberty is applied.He stated he did not have any issues for 3 years of product use until he started taking the medication spironolactone.Patient stated he tried a skin test of men's liberty at the advice of his dermatologist, and that he did not have any reaction to men's liberty during his skin test.
Additional Manufacturer Narrative
Patient supplied the udi from his product which includes the product lot # k32613.Manufacturing records were reviewed, and there were no discrepancies noted.There were no nonconformances associated with this lot.It is also unclear whether the patient has spoken to our medical product specialists for troubleshooting on this matter.In the report, patient stated he has been using ml for 3 years, but we are unable to retrieve patient notes in our system without any identifying information.It is unknown what could cause the patient to experience sores and blisters if he successfully used the product for 3 years and had no reaction during a skin test.Without more information, this complaint cannot be investigated further.This is also being reported to the fda by argentum in an abundance of caution.

• 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
• MDR Report Key: 22301746
• Report Number: 3003622638-2025-00001
• Device Sequence Number: 8628636
• Product Code: NOA
• UDI-Device Identifier: 00653599000168
• UDI-Public: (01)00653599000168(10)K32613(17)270331
• Combination Product (Y/N): N
• 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): 06/19/2025

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: K32613
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/21/2024
• 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: Other
• Patient Sex: Unknown