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 06/01/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, neotract was made aware of a patient who received a successful prostatic urethral lift (pul) procedure in february 2022.It was reported that the patient experienced continued urinary symptoms and four (4) urinary tract infections since the procedure.On (b)(6) 2023, it was further reported that since the procedure, the patient had been hospitalized between one (1) and four (4) days on three (3) occasions for urinary tract infections, and had received iv antibiotic on two (2) occasions.The patient continued to experience urinary symptoms and had an unspecified outpatient surgery scheduled with his urologist to address his continued symptoms.

• Brand Name: NEOTRACT UROLIFT SYSTEM
• Type of Device: UROLIFT SYSTEM
• Manufacturer (Section D): NEOTRACT, INC.; 4155 hopyard road; pleasanton CA 94588
• Manufacturer Contact: brian gall ; 4155 hopyard road; pleasanton, CA 94588 ; 9253296547
• MDR Report Key: 16281371
• MDR Text Key: 308606719
• Report Number: 3015181082-2023-00005
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• 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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Sex: Male