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 Problem Hematoma (1884)

Event Date 01/08/2024

Event Type  Injury  

Event Description

On (b)(6) 2024, the patient underwent prostatic urethral lift procedure which was uneventful.Post procedure, the same day, the patient experienced severe pain and was diagnosed with pelvic hematoma and low hemoglobin level.He was hospitalized for blood transfusion and for angiographic embolization which was unsuccessful, and the patient was discharged.4-5 days later the patient presented with fever and was hospitalized for precaution.No additional information was received.

Manufacturer Narrative

Teleflex aware date is updated from 10-jan-2024 to (b)(6) 2024.Section e1- primary reporter facility name added - parkway surgery center.

• 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; MX
• Manufacturer Contact: nikitha penumentsa ; 4155 hopyard road; pleasanton, CA ; 9195448000
• MDR Report Key: 18646796
• MDR Text Key: 334614398
• Report Number: 3015181082-2024-00006
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• 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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White