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 10/06/2022

Event Type  Injury  

Event Description

On 6 october 2022, neotract was made aware of a patient who received a successful prostatic urethral lift (pul) procedure on an unspecified date.It was reported that approximately six weeks after the procedure, the patient was diagnosed with an e.Coli urinary tract infection, which was unsuccessfully treated with multiple rounds of oral antibiotics.The patient was then treated with a course of intravenous antibiotics, which cleared the infection.The patient was reported to be doing fine post treatment.

• 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: 15739682
• MDR Text Key: 303141661
• Report Number: 3015181082-2022-00039
• 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
• Report Date: 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• 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: 10/06/2022
• 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): Other
• Patient Sex: Male