MAUDE Adverse Event Report: HUDSON RESPIRATORY CARE TECATE NEOTRACT UROLIFT 2 SYSTEM

Model Number	UROLIFT 2 SYSTEM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On february 05, 2025, neotract has been made aware that ¿a patient underwent a urolift procedure in which five implants were placed and was discharged to home with a catheter.The night post-procedure the patient passed out and sought medical attention.Upon evaluation, it was observed that the patient had significant pelvic bleeding due to pelvic hematoma.The patient received blood transfusions as part of the treatment.¿.
Additional Manufacturer Narrative
Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review could not be conducted since the lot number of the device was not provided.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.If the sample becomes available at a later date a follow-up report will be submitted with investigation results.Neotract will continue to monitor and trend for reports of this nature.

• Brand Name: NEOTRACT UROLIFT 2 SYSTEM
• Common Device Name: UROLIFT 2 SYSTEM
• Manufacturer (Section D): HUDSON RESPIRATORY CARE TECATE; prolongacion mision eusebio ki; no. 1316, rancho el descanso; tecate ; MX
• Manufacturer (Section G): HUDSON RESPIRATORY CARE TECATE; prolongacion mision eusebio; no. 1316, rancho el descanso; tecate ; MX
• Manufacturer Contact: laura gonzalez serrano ; 4155 hopyard road; pleasanton, CA 94588 ; 9195448000
• MDR Report Key: 21510612
• Report Number: 3015181082-2025-00039
• Device Sequence Number: 7962824
• Product Code: PEW
• UDI-Device Identifier: 10814932020343
• UDI-Public: 10814932020343
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K201837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/03/2025

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
• Operator of Device: Health Professional
• Device Model Number: UROLIFT 2 SYSTEM
• Device Catalogue Number: IPN924184
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 03/03/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male