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)
Date of Event	08/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 set up was conducted.Patient history notes showed reoccurring history of urinary incontinence bladder and retention issues.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 it is unclear from their report.Product specialist followed up with patient on (b)(6) 2024, but patient stated he didn't have time for any f/u questions and to call back in a few weeks.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.
Event or Problem Description
Product specialist reached out to the patient regarding reordering and was informed that the patient is not currently using ml.Patient stated he fell in the bathroom wearing ml and was unable to get off the ground for 14 hours before getting help to the hospital.Patient stated he wasn't aware he had a uti until being diagnosed at hospital.Patient stated at the hospital sent him home without any antibiotics, leading to a relapse.Patient stated he prefers to wear ml over depends/absorbent pads but is afraid to wear ml after suffering from uti.Product specialist reached out to the doctor on 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): BIODERM, INC.; 12320 73rd court n; largo FL 33773
• Manufacturer Contact: julie schillo ; 12320 73rd court n; largo, FL 33773 ; 7274162685
• MDR Report Key: 20745049
• Report Number: 3001949129-2024-00001
• Device Sequence Number: 8614074
• Product Code: NOA
• UDI-Device Identifier: 00653599000168
• UDI-Public: (01)00653599000168(10)K10707(17)260831
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/19/2024

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: K10707
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• 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