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 was contacted on (b)(6) 2022 for follow-up to first-time product use.Patient's wife stated that the patient was hospitalized due to uti after starting use of men's liberty.Patient's wife stated that he wore one ml for 3 days, developed an infection, was in the hospital, and to call her back later.Product specialist called back.Patient's wife stated he would start using ml again now that he is cleared of infection.Product specialist gave her suggestion for recommended wear time (24 hours), proper positioning to help prevent backflow, and what to watch for.Patient's wife was unable to provide the men's liberty lot number.
Additional Manufacturer Narrative
Hospital or doctor's notes confirming the reported infection were not received.Patient's wife wouldn't report where he was seen or treated.There are no notes on patient medical history to review.Patient's wife was also unable to provide a lot number, so manufacturing records could not be reviewed.Report will be updated if further information or notes on patient medical history 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.

• 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: 15564321
• Report Number: 3001949129-2022-00008
• Device Sequence Number: 5593745
• Product Code: NOA
• UDI-Device Identifier: 00653599000847
• UDI-Public: 00653599000847
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/07/2022

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 Model Number: 23046
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2022
• Initial Report FDA Received Date: 10/07/2022
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Male