MAUDE Adverse Event Report: NEOTRACT, INC. NEOTRACT UROLIFT SYSTEM UL400

Model Number UL400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Urinary Tract Infection (2120)

Event Date 12/28/2018

Event Type  Injury  

Event Description

On 3 september 2019, neotract was notified about a patient, with a history of nocturia, recurrent prostate infections, and allergy to multiple antibiotics, who underwent a successful prostatic urethral lift (pul) procedure with the urolift system on (b)(6) 2018.Post procedure, the patient was discharged with a catheter.A couple of days later, he experienced a fever and received antibiotics.After several trials without a catheter, he was advised to self catheterize for approximately three (3) months.At a four (4) month follow up appointment, a urine culture was positive for bacteria.On (b)(6) 2019, he was admitted to the hospital for three (3) days and received iv antibiotics.At a follow up appointment with his primary care physician, he was instructed to take antibiotic shots for ten (10) days.On (b)(6) 2019, two of the five implants were removed.The patient reported that he no longer self catheterizes and stated he feels much better.

• Brand Name: NEOTRACT UROLIFT SYSTEM UL400
• Type of Device: UROLIFT SYSTEM
• Manufacturer (Section D): NEOTRACT, INC.; 4473 willow road suite 100; pleasanton CA 94588
• Manufacturer (Section G): NEOTRACT, INC.; 4473 willow road suite 100; pleasaonton CA 94588
• Manufacturer Contact: brian gall ; 4155 hopyard road; pleasanton, CA 94588 ; 9253296547
• MDR Report Key: 9151625
• MDR Text Key: 162460804
• Report Number: 3005791775-2019-00035
• Device Sequence Number: 1
• Product Code: PEW
• UDI-Device Identifier: 00814932020001
• UDI-Public: 00814932020001
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/03/2019

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
• Device Operator: Health Professional
• Device Model Number: UL400
• Device Catalogue Number: AN00090
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/03/2019
• Initial Date FDA Received: 10/03/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention