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 Hematoma (1884); Low Blood Pressure/ Hypotension (1914); Pain (1994)

Event Date 02/21/2024

Event Type  Injury  

Event Description

On 28feb2024 neo tract was made aware of a 58-year-old patient who underwent a prostatic urethral lift on (b)(6) 2024.The procedure was uneventful, with four implants placed along with a pre-planned transurethral incision of the prostate as the patient had a high bladder neck.On 21 feb 2021, while the patient was still in hospital, he suffered severe abdominal pain, dizziness, and hypotension.Mri scan revealed a pelvic hematoma.The patient received one unit of blood transfusion and was hospitalized for three days.On (b)(6) 2024, the patient was discharged and reported to be doing well.No other additional interventions were required and his post-op follow-up was scheduled for 14 march 2024.

• 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: nikitha penumetsa ; 4155 hopyard road; pleasanton 94588 ; 9195448000
• MDR Report Key: 18991057
• MDR Text Key: 338889969
• Report Number: 3015181082-2024-00011
• 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: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UROLIFT 2 SYSTEM¿
• Device Catalogue Number: IPN924184
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• 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
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White