MAUDE Adverse Event Report: BIODERM, INC. 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
Event or Problem Description
Patient's wife called in reporting the patient was in the hospital with a uti after using men's liberty.She stated he was put on 5 days of antibiotics.She mentioned that a small portion of urine in the ml tube doesn't drain down into the collection pouch.Product specialist went over application and troubleshooted ways to ensure proper drainiage of urine.Patient's wife stated that she applies the faceplate seal tightly, and the product specialist informed her to apply correctly without it being too tight to prevent injury.Patient's wife stated they would refrain from using ml for another week until he is cleared of the uti.She also mentioned he has had utis in the past but nothing chronic.Patient's wife provided ml lot # k17601.Product specialist reached out to the doctor on file to request doctor's notes on patient medical history and confirmation of infection but was unsuccessful.
Additional Manufacturer Narrative
Manufacturing records for this lot were reviewed, and there were no discrepancies noted.There were no nonconformances associated with this lot.Product retain drained properly when tested with water.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, acute cystitis with hematuria, and a previous uti.The patient's medical history of incontinence could contribute to an infection, as incontinence patients are at a higher risk for infection, but the cause of this report is unclear.Product specialist followed up with patient's wife on 09/17/24, and she stated everything is going good.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 infection are received.

• Brand Name: MEN'S LIBERTY
• Common Device Name: EXTERNAL CATHETER
• Manufacturer (Section D): BIODERM, INC.; 12320 73rd court n; largo FL 33773
• Manufacturer Contact: julie schillo ; 12320 73rd court n.; largo, FL 33773 ; 7274162685
• MDR Report Key: 20745360
• Report Number: 3001949129-2024-00002
• Device Sequence Number: 8483706
• Product Code: NOA
• UDI-Device Identifier: 00653599000168
• UDI-Public: (01)00653599000168(10)K17601(17)270331
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/27/2024

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: K17601
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 11/21/2024
• 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