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	11/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing records for the lot were reviewed, and there were no discrepancies or nonconformances noted.Hospital and/or doctor's notes confirming the uti were requested.Doctor's notes were received and reviewed.Unable to confirm uti based on the notes received.Notes showed patient history of urinary incontinence, bladder issues, and cystoscopy.The patient was admitted and treated for vomiting, diarrhea, dehydration, and a-fib w/ rvr.It is possible that the patient's medical history of urinary incontinence contributed to an infection, but since it could not be confirmed how he was using the product, the cause cannot be established.Incontinence patients are at a higher risk for infection.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 will be reported.Report will be updated if further information is received.
Event or Problem Description
Patient called in to report that he was in the hospital for 5 days with a uti.Patient stated he has had them before, and not quite sure what caused it.Patient stated he is currently using a foley catheter and is not sure for how long.Patient was unable to provide a men's liberty lot number.Per sap notes, the patient was shipped men's liberty lot # j19107.

• Brand Name: MEN'S LIBERTY
• Common Device Name: EXTERNAL CATHETER
• Manufacturer (Section D): BIODERM, INC.; 12320 73rd court n; largo FL 33773
• Manufacturer Contact: stephanie conner ; 12320 73rd court n.; largo, FL 33773 ; 7274162685
• MDR Report Key: 18273681
• Report Number: 3001949129-2023-00003
• Device Sequence Number: 5414016
• Product Code: NOA
• UDI-Device Identifier: 00653599000168
• UDI-Public: 00653599000168
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 12/06/2023

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: J19107
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2023
• Initial Report FDA Received Date: 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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