MAUDE Adverse Event Report: NEOTRACT, INC. NEOTRACT UROLIFT 2 SYSTEM

Model Number UROLIFT 2 SYSTEM

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

Patient Problems Hematoma (1884); Pain (1994); Syncope/Fainting (4411)

Event Date 06/25/2022

Event Type  Injury  

Event Description

On 22 july 2022, neotract was made aware of a patient who received a successful prostatic urethral lift (pul) procedure on (b)(6) 2022.It was reported that the patient started a blood thinner one day post-procedure and developed pain, fever, syncope, and a hematoma.The patient was admitted to the hospital for five days and experienced an episode of syncope.The physician reported that as of (b)(6) 2022, the hematoma had partially resolved.No additional information about the patient was available.

• Brand Name: NEOTRACT UROLIFT 2 SYSTEM
• Type of Device: UROLIFT 2 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: 15259726
• MDR Text Key: 298230457
• Report Number: 3015181082-2022-00023
• Device Sequence Number: 1
• Product Code: PEW
• UDI-Device Identifier: 10814932020206
• UDI-Public: 10814932020206
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201837
• 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: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UROLIFT 2 SYSTEM
• Device Catalogue Number: IPN056885
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2022
• 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
• Patient Sex: Male