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

Model Number UL400

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

Patient Problem Sepsis (2067)

Event Date 03/03/2018

Event Type  Injury  

Event Description

On 02 march 2020, neotract was made aware of a retrospective study patient who underwent a successfully completed prostatic urethral lift (pul) procedure on (b)(6) 2018.On (b)(6) 2018, it was reported tha the patient presented to the er due to suspected uti.It was stated that the patient experienced urosepsis requiring hospitalization for four days.On (b)(6) 2018, the event was resolved.No additional information available despite multiple outreach attempts.

• Brand Name: NEOTRACT UROLIFT SYSTEM
• Type of Device: UROLIFT SYSTEM
• Manufacturer (Section D): NEOTRACT, INC.; 4155 hopuard road; pleasanton CA 94588
• Manufacturer (Section G): NEOTRACT, INC.; 4155 hopyard road; pleasanton CA 94588
• Manufacturer Contact: kathyrene logrono ; 4155 hopyard road; pleasanton, CA 94588 ; 9253296521
• MDR Report Key: 9909152
• MDR Text Key: 191915410
• Report Number: 3005791775-2020-00019
• Device Sequence Number: 1
• Product Code: PEW
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/31/2020

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other