MAUDE Adverse Event Report: NEOTRACT, INC. UROLIFT; IMPLANTABLE TRANSPROSTATIC TISSUE RETRACTOR SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Urinary Tract Infection (2120); Blood Loss (2597)

Event Date 08/02/2019

Event Type  Injury  

Event Description

Excessive bleeding x 3 days excessive pain in pelvis and penis.Need for straight cath to void then foley cath placed.Uti.Urolift procedure.Fda safety report id # (b)(4).

• Brand Name: UROLIFT
• Type of Device: IMPLANTABLE TRANSPROSTATIC TISSUE RETRACTOR SYSTEM
• Manufacturer (Section D): NEOTRACT, INC.
• MDR Report Key: 8893587
• MDR Text Key: 154473865
• Report Number: MW5089012
• Device Sequence Number: 1
• Product Code: PEW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 66 YR