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	06/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient's wife reported her husband was hospitalized with uti while using men's liberty.She stated the weight of the bag was pulling on him and not draining into the bed bag.She stated they only used men's liberty 3 times.Patient's wife stated this is the first time he has had a uti.Product specialist followed up with the patient's wife the next day.Patient's wife stated he sleeps mostly on his back, hardly turns, and wears briefs.She also mentioned finding the ml bag stuck under his leg.Product specialist explained proper positioning, how that affects urine flow away from the anatomy with gravity, and that an obstruction could cause urine to back up.Patient's wife stated he was treated with cipro antibiotics, but his condition worsened.She stated he experienced shaking, losing consciousness, and an altered mental state.She stated he was then hospitalized to receive iv antibiotics.Patient's wife called back in on (b)(6) 2022 to report he was home and doing better, but she is not using the product anymore.
Additional Manufacturer Narrative
Manufacturing records for the lot were reviewed, and there were no discrepancies or nonconformances noted.A product retain for this lot was tested with water and drained as intended.Hospital and/or doctor's notes confirming the uti or hospitalization were requested and never received.Patient's wife did not give consent to release records.Report will be updated if notes or further information is received.Incontinence patients are at a higher risk for infection.Per patient's wife, he is home, doing better, and won't be using the product anymore.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: 14950206
• Report Number: 3001949129-2022-00007
• Device Sequence Number: 6953089
• Product Code: NOA
• UDI-Device Identifier: 00653599000168
• UDI-Public: 00653599000168
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 07/07/2022

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: H10401
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2022
• Initial Report FDA Received Date: 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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