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 Bacterial Infection (1735); Urinary Retention (2119)

Event Date 10/05/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, neotract was made aware of a patient who received a successful prostatic urethral lift (pul) procedure on (b)(6) 2021.As a pre-procedural antibiotic, the patient was prescribed ancef.In the days following the procedure (timing unknown), the patient underwent emergency hemorrhoid surgery which urologist said was ¿unrelated to the pul procedure.¿ post hemorrhoid surgery, the patient experienced urinary retention.On (b)(6) 2021, he was admitted to the hospital for a c.Difficile infection, thought to be related to the ancef medication and not to the pul procedure.Ct imaging revealed air in his pelvis.Patient was transferred to the icu for two weeks for unknown reasons, has since been discharged and reported as doing well.The urologist stated that he believed the infection, urinary retention, and pelvic air were unrelated to the pul procedure.

• 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: 12849499
• MDR Text Key: 282499616
• Report Number: 3015181082-2021-00038
• Device Sequence Number: 1
• Product Code: PEW
• UDI-Device Identifier: 00814932020001
• UDI-Public: 00814932020001
• 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: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• 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: UL400-4
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2021
• 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; Required Intervention
• Patient Sex: Male