MAUDE Adverse Event Report: NEOTRACT, INC NEOTRACT UROLIFT SYSTEM

Model Number	UROLIFT SYSTEM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Urinary Tract Infection (2120)
Date of Event	02/06/2023
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: 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
• Report Number: 3015181082-2023-00013
• Device Sequence Number: 6382237
• Product Code: PEW
• UDI-Device Identifier: 00814932020087
• UDI-Public: 00814932020087
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K193269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/07/2023

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
• Operator of Device: Health Professional
• Device Model Number: UROLIFT SYSTEM
• Device Catalogue Number: IPN055826
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2023
• Initial Report FDA Received Date: 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Male