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	05/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hospital and/or doctor's notes confirming the uti or hospitalization were requested and never received.Doctor's notes listing medical history during patient set-up were reviewed.Patient notes mention the patient had to quit taking a medication for recurrent uti/cystitis due to serious side effects.Patient stated he has a history of urinary tract infections.Patient was also using absorbent products with men's liberty which could cause excess moisture around the anatomy.Report will be updated if further notes are received.There is no confirmed history of infection related to our product.There is no indication that the device failed to meet specifications or malfunctioned, and the cause is not established.
Event or Problem Description
Patient was contacted for product use follow up.He stated he currently has a uti while using men's liberty and is hospitalized due to the infection.Patient stated he has a history of uti, and this is the third uti.Patient stated he was treated with cipro and other antibiotic for an unrelated issue.Bioderm product specialist went over the application steps and product use instructions.Patient stated he was using adult diapers with men's liberty.The product specialist explained the recommended underwear and when to drain and empty the men's liberty urine collection pouch.Patient stated he will resume use of men's liberty when his antibiotics are complete.

• Brand Name: MEN'S LIBERTY
• Common Device Name: EXTERNAL CATHETER
• Manufacturer (Section D): BIODERM, INC.; 12320 73rd court n.; largo FL 33773
• Manufacturer Contact: 12320 73rd court n.; largo, FL 33773
• MDR Report Key: 14700102
• Report Number: 3001949129-2022-00003
• Device Sequence Number: 17794189
• Product Code: NOA
• UDI-Device Identifier: 00653599000168
• UDI-Public: 00653599000168
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 06/15/2022

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 Expiration Date: 07/31/2024
• Device Model Number: 23046
• Device Lot Number: H10801
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2022
• Initial Report FDA Received Date: 06/15/2022
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Male