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 Problems Pain (1994); Urinary Tract Infection (2120)

Event Date 02/06/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, neotract was made aware of a patient that received a prostatic urethral lift (pul) procedure on an unspecified date.It was reported that approximately six weeks post procedure, the patient began experiencing urinary symptoms and pain.The patient was hospitalized and subsequently diagnosed with an infection that traveled to the patient¿s blood stream.The patient was treated with intravenous antibiotics for approximately sixteen weeks, which cleared the infection.The patient continues to experience urinary symptoms and is taking oral medication to address the continued symptoms.

• 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: 16499810
• MDR Text Key: 310852737
• Report Number: 3015181082-2023-00013
• Device Sequence Number: 1
• Product Code: PEW
• UDI-Device Identifier: 00814932020087
• UDI-Public: 00814932020087
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2023
• 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: IPN055826
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/06/2023
• 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; Other
• Patient Sex: Male