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

Model Number UROLIFT SYSTEM

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

Patient Problems Sepsis (2067); Urinary Tract Infection (2120)

Event Date 06/11/2019

Event Type  Injury  

Event Description

On (b)(4) 2019, neotract was made aware of a patient who had a successful prostatic urethral lift (pul) procedure done on (b)(6) 2018.It was reported that the patient had ongoing complaints of recurring urinary tract infections (uti) following the pul.On june 11, 2019, neotract received additional information that on two occasions, the patient was hospitalized: (b)(6) 2019 for 2 days and on (b)(6) 2019, an overnight stay.Both hospitalizations were due to utis that turned septic.The patient received iv antibiotics for both hospitalizations.On (b)(6) 2019, it was reported that the implants were explanted prior to a turp (transurethral resection of the prostate) procedure.Post-turp symptoms were reported to include continued dysuria.

• 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; pleasanton CA 94588
• Manufacturer Contact: kathyrene logrono ; 4155 hopyard road; pleasanton, CA 94588 ; 9253296521
• MDR Report Key: 8774237
• MDR Text Key: 150532908
• Report Number: 3005791775-2019-00024
• Device Sequence Number: 1
• Product Code: PEW
• UDI-Device Identifier: 00814932020001
• UDI-Public: 00814932020001
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/09/2019

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: UROLIFT SYSTEM
• Device Catalogue Number: AN00090
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/11/2019
• Initial Date FDA Received: 07/09/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention