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

Model Number UROLIFT SYSTEM

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

Patient Problems Fever (1858); Hemorrhage/Bleeding (1888)

Event Date 11/23/2023

Event Type  Injury  

Event Description

On 28 nov 2023, neotract was made aware of a patient that received a prostatic urethral lift (pul) procedure on (b)(6) 2023.During the procedure, hematuria with a blood clot was observed.In the recovery room, the patient developed urinary retention and he was catheterized.On (b)(6) 2023, the patient's hemoglobin level decreased by 2 g/dl from baseline.A computed tomography (ct) scan was performed with no visible hematoma.The patient underwent bladder irrigation on (b)(6) 2023 and (b)(6) 2023 with persisting hematuria, decreasing hemoglobin levels, and a low grade fever.On (b)(6) 2023, the catheter was removed.It was reported that hematuria, urethral pain, and decreased hemoglobin levels persisted, so the patient continued to be transfused (2 units total).On (b)(6) 2023, the patient was discharged with no plans of additional scans or interventions.

• Brand Name: NEOTRACT UROLIFT SYSTEM
• Type of Device: UROLIFT 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: 18267652
• MDR Text Key: 329736133
• Report Number: 3015181082-2023-00042
• Device Sequence Number: 1
• Product Code: PEW
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K193269
• 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: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UROLIFT SYSTEM
• Device Catalogue Number: IPN924183
• Device Lot Number: 73H2300634
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2023
• 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; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male