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

Model Number UROLIFT SYSTEM

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

Patient Problem Urinary Tract Infection (2120)

Event Date 05/17/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, neotract was made aware of an adverse event from the clear study.On 17 may 2022, a patient underwent a successful prostatic urethral lift (pul) procedure and was catheterized without a void trial.It was reported that the patient had two unsuccessful void trials and presented to urgent care on (b)(6) 2022, where he was diagnosed with a uti and prescribed an oral antibiotic.On (b)(6) 2022 he presented to the er and was admitted and prescribed iv and oral antibiotics.His catheter was removed and he was discharged from the hospital on (b)(6) 2022 with oral antibiotics.

Manufacturer Narrative

On 24 oct 2023, additional information was received indicating that the clinical trial patient underwent removal of 3 implants and had a greenlight laser procedure on (b)(6) 2022 as his bph symptoms had not improved.

• Brand Name: NEOTRACT UROLIFT SYSTEM
• Type of Device: UROLIFT SYSTEM
• Manufacturer (Section D): NEOTRACT, INC.; 4155 hopyard road; pleasanton CA 94588
• Manufacturer (Section G): NEOTRACT, INC.; 4155 hopyard road; pleasanton CA 94588
• Manufacturer Contact: brian gall ; 4155 hopyard road; pleasanton, CA 94588 ; 9253296547
• MDR Report Key: 14795013
• MDR Text Key: 295037450
• Report Number: 3015181082-2022-00011
• Device Sequence Number: 1
• Product Code: PEW
• UDI-Device Identifier: 10814932020275
• UDI-Public: 10814932020275
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2022
• 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: IPN918876
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Sex: Male