MAUDE Adverse Event Report: NEOTRACT, INC. NEOTRACT UROLIFT SYSTEM UL400

Model Number UL400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematoma (1884)

Event Date 07/12/2017

Event Type  Injury  

Event Description

On 24 april 2020, neotract was notified of an adverse event from the real world retrospective study: on (b)(6) 2017, a patient underwent a successful prostatic urethral lift (pul) procedure.Post procedure, the patient was discharged with a catheter.It was reported that the patient experienced severe bleeding requiring hospitalization for clot evacuation, prostate fulguration, and blood transfusion.The event resolved the next day.No additional information was available.

• Brand Name: NEOTRACT UROLIFT SYSTEM UL400
• Type of Device: UROLIFT SYSTEM
• Manufacturer (Section D): NEOTRACT, INC.; 4155 hopyard rd.; pleasanton CA 94588
• Manufacturer (Section G): NEOTRACT, INC.; 4155 hopyard rd.; pleasanton CA 94588
• Manufacturer Contact: brian gall ; 4155 hopyard rd; pleasanton, CA 94588 ; 9253296547
• MDR Report Key: 10081173
• MDR Text Key: 192141196
• Report Number: 3005791775-2020-00024
• 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: K173087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/21/2020

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
• Device Operator: Health Professional
• Device Model Number: UL400
• Device Catalogue Number: AN00094
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2020
• Initial Date FDA Received: 05/21/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention