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 Problems Pain (1994); Urinary Retention (2119); Hematuria (2558)

Event Date 12/05/2023

Event Type  Injury  

Event Description

On 12 dec 2023, neotract was made aware of a patient who received a successful prostatic urethral lift (pul) procedure on (b)(6) 2023.Three days post procedure, the patient experienced hematuria with blood clots and pain.Patient present to the er where he underwent a bladder irrigation, and a catheter was placed.Patient removed the catheter post placement due to severe pelvic pain.On (b)(6) 2023, he continued to experience hematuria with blood clots and presented himself to the er due to the inability to urinate.He underwent a second bladder irrigation, cauterization of blood vessels, and was admitted for one day.He was discharged on (b)(6) 2023 with a larger catheter.On (b)(6) 2023 he experienced hematuria with blood clots and pelvic pain, so he presented to the er where he was admitted.

• 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: 18489442
• MDR Text Key: 332602121
• Report Number: 3015181082-2024-00002
• Device Sequence Number: 1
• Product Code: PEW
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/12/2023
• 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 Sex: Male