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); Swelling/ Edema (4577)

Event Date 08/16/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, neotract was made aware of a patient that received a prostatic urethral lift (pul) procedure on (b)(6) 2023.Approximately two days post procedure, the patient experienced flank pain and went to the emergency department.A ct scan revealed hydronephrosis and a capsular tab was impinged on the ureter.The capsular tab was removed with graspers and a stent was placed.The patient was hospitalized for 1 day.Approximately two weeks later the stent was removed.The patient 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: elizabeth ashworth ; 4155 hopyard road; pleasanton, CA 94588 ; 9253296525
• MDR Report Key: 17865458
• MDR Text Key: 324865746
• Report Number: 3015181082-2023-00037
• 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: 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2023
• 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: 09/07/2023
• 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