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 Problem Urinary Tract Infection (2120)

Event Date 10/28/2022

Event Type  Injury  

Event Description

On (b)(6) 2023, neotract was made aware of a patient who received a successful prostatic urethral lift (pul) procedure on (b)(6) 2022.It was reported that approximately one week after the procedure, the patient experienced discomfort and was further diagnosed with a urinary tract infection requiring hospitalization and intravenous antibiotics.It was reported that the symptoms have completely resolved.

• 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: 16724841
• MDR Text Key: 313152996
• Report Number: 3015181082-2023-00027
• Device Sequence Number: 1
• Product Code: PEW
• UDI-Device Identifier: 10814932020275
• UDI-Public: 10814932020275
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2023
• 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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/23/2023
• 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