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
Additional Manufacturer Narrative
No lot number or further information was received to look at manufacturing records.Unable to investigate further without a lot number.Hospital notes confirming the uti and hospitalization were requested and received on 10/06/23.Doctor's notes were reviewed and showed a positive uti diagnosis, which was treated with levaquin.Hospital notes list a patient history of urinary flow issues after spinal surgery.Patient was a new user and has not reported this previously.Patient stated he was not emptying the men's liberty pouch frequently enough, which could cause urine to stay near the anatomy.We are unable to confirm if the infection was caused by our device as incontinent patients are at a higher risk for infection.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 on (b)(6) 2023 for follow-up to first-time product use.Patient stated he loves the product, and it worked fine, but after 3 days of use he started to experience burning while urinating.Patient stated he probably wasn't emptying out the pouch as often as he should have.Product specialist explained to empty the pouch when it was 3/4 full.Patient stated he was not doing that.Patient stated he ended up in the hospital with a uti, which turned into sepsis.Patient stated he is currently in the hospital and being discharged tomorrow.Patient is at the (b)(6) hospital.Patient was unable to provide the men's liberty lot number.

• Brand Name: MEN'S LIBERTY
• Common Device Name: EXTERNAL CATHETER
• Manufacturer (Section D): BIODERM, INC.; 12320 73rd court north; largo FL 33773
• Manufacturer Contact: stephanie conner ; 12320 73rd court north; largo, FL 33773
• MDR Report Key: 17975392
• Report Number: 3001949129-2023-00001
• Device Sequence Number: 3470980
• Product Code: NOA
• UDI-Device Identifier: 00653599000168
• UDI-Public: 00653599000168
• 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): 10/19/2023

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 10/20/2023
• 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