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 Hemorrhage/Bleeding (1888); Embolism/Embolus (4438)

Event Date 02/24/2023

Event Type  Injury  

Event Description

The information in this section was reported to neotract by the patient.On (b)(6) 2023, neotract was made aware of a patient that received a prostatic urethral lift (pul) procedure on (b)(6) 2023.Post procedure, the patient experienced bleeding that required catheterization and continuous bladder irrigation.The patient was admitted to the hospital and underwent two additional unspecified procedures to control the bleeding.The patient was further diagnosed with a "heart flutter" while in the hospital and developed blood clots to his legs and lungs, which may require further intervention.The patient reported being in the icu, having a lot of pain and occasionally feeling dizzy.As of (b)(6) 2023, the patient was still in the hospital experiencing bleeding and clotting.No additional information about the patient was available.

• 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: kathleen shin ; 4155 hopyard road; pleasanton, CA 94588 ; 9252080692
• MDR Report Key: 16620783
• MDR Text Key: 312067500
• Report Number: 3015181082-2023-00023
• Device Sequence Number: 1
• Product Code: PEW
• UDI-Device Identifier: 10814932020275
• UDI-Public: 10814932020275
• Combination Product (y/n): N
• PMA/PMN Number: K193269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2023
• 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: IPN918876
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2023
• 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): Other; Hospitalization
• Patient Sex: Male