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

Device Problems Calcified (1077); Material Protrusion/Extrusion (2979)

Patient Problems Incontinence (1928); Pain (1994); Urinary Tract Infection (2120); Drug Resistant Bacterial Infection (4553)

Event Date 03/23/2021

Event Type  Injury  

Event Description

Constant infections the last one, resistant, to oral medication.I had a urolift device placed in my prostate, on (b)(6) 2018, which left me with constant uti's.On (b)(6) 2020, i had a procedure, called rexum, which opened up my urethra, but still had the infections.After checking, with a scope, the urolift device, was now exposed and had calcium deposits.Dr.(b)(6), then decided, that the urolift device had to be removed, which resulted in an infection, resistant to oral medication; still dealing with pain but most uncomfortable "im now incontinent, having to wear depends".

• Brand Name: UROLIFT IMPLANT
• Type of Device: IMPLANTABLE TRANSPROSTATIC TISSUE RETRACTOR SYSTEM
• Manufacturer (Section D): NEOTRACT INC.
• MDR Report Key: 11885317
• MDR Text Key: 253492697
• Report Number: MW5101547
• Device Sequence Number: 1
• Product Code: PEW
• Combination Product (y/n): Y
• 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: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 73