MAUDE Adverse Event Report: NEOTRACT, INC. UROLIFT 2 IMPLANT CARTRIDGE; IMPLANTABLE TRANSPROSTATIC TIS

Catalog Number	UL2-C
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	06/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "after the procedure and while in recovery, the patient that received the urolift began to present with increasing tightness of the abdomen.The patient was ordered a ct, which confirmed a hematoma in the patient's pelvic area.At this time, the patient's symptoms do not appear to be worsening.The patient is being admitted overnight for observation".Additional information states that the patient is now "discharged from the hospital".
Additional Manufacturer Narrative
Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
It was reported that "after the procedure and while in recovery, the patient that received the urolift began to present with increasing tightness of the abdomen.The patient was ordered a ct, which confirmed a hematoma in the patient's pelvic area.At this time, the patient's symptoms do not appear to be worsening.The patient is being admitted overnight for observation".Additional informaiton states that the patient is now "discharged from the hospital".

• Brand Name: UROLIFT 2 IMPLANT CARTRIDGE
• Common Device Name: IMPLANTABLE TRANSPROSTATIC TIS
• Manufacturer (Section D): NEOTRACT, INC.; pleasanton
• Manufacturer (Section G): NEOTRACT, INC.; 4155 hopyard road; pleasanton
• Manufacturer Contact: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 22321490
• Report Number: 3015181082-2025-00016
• Device Sequence Number: 8923940
• Product Code: PEW
• UDI-Device Identifier: 10814932020121
• UDI-Public: (01)10814932020121(11)240528(17)260528(10)73E2401052(21)
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K201837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 05/28/2026
• Device Catalogue Number: UL2-C
• Device Lot Number: 73E2401052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown