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

Model Number UROLIFT 2 SYSTEM

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

Patient Problem Hematoma (1884)

Event Date 11/30/2023

Event Type  Injury  

Event Description

On 13 dec 2023, neotract was made aware of a patient that received a prostatic urethral lift (pul) procedure on (b)(6) 2023.On the same day after the procedure, the patient was diagnosed with a pelvic hematoma, confirmed by ct scan, and underwent embolization.The patient was hospitalized for one night and was discharged.The patient status was reported to be doing well.

• Brand Name: NEOTRACT UROLIFT 2 SYSTEM
• Type of Device: 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 ki; no. 1316,rancho el descanso; tecate ; MX
• Manufacturer Contact: marling heaton ; 4155 hopyard road; pleasanton, CA 94588 ; 9194332664
• MDR Report Key: 18482668
• MDR Text Key: 332495018
• Report Number: 3015181082-2024-00001
• Device Sequence Number: 1
• Product Code: PEW
• UDI-Device Identifier: 10814932020343
• UDI-Public: 10814932020343
• 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: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• 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: IPN924184
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention; Hospitalization
• Patient Sex: Male