MAUDE Adverse Event Report: NEOTRACT, INC. NEOTRACT UROLIFT SYSTEM UL400

Model Number UL400

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

Patient Problem Unspecified Infection (1930)

Event Date 05/24/2018

Event Type  Injury  

Event Description

On (b)(6) 2020, neotract was notified of a successfully completed prostatic urethral lift (pul) procedure performed on (b)(6) 2018.In (b)(6) 2018, it was reported that the patient developed perineal pain and was treated with multiple antibiotic and anti-inflammatory drugs due to suspected bacterial prostatitis.In (b)(6) 2018, it was reported that the patient presented to the er due to intense pain.In (b)(6) 2019, the patient was described to have minor swelling of the penis and was placed on antibiotics.In (b)(6) 2019, it was reported that the patient was treated with turp, and three implants were removed.Subsequently (in (b)(6) 2020), the patient reported continued swelling and pain of the penis, scrotal and perineal area.No additional information is available on the patient¿s status at this time.

• Brand Name: NEOTRACT UROLIFT SYSTEM UL400
• Type of Device: UROLIFT SYSTEM
• Manufacturer (Section D): NEOTRACT, INC.; 4155 hopyard road; pleasanton CA 94588
• Manufacturer (Section G): NEOTRACT, INC.; 4155 hopyard road; pleasanton CA 94588
• Manufacturer Contact: brian gall ; 4155 hopyard road; pleasanton, CA 94588 ; 9253296547
• MDR Report Key: 10645807
• MDR Text Key: 210429750
• Report Number: 3005791775-2020-00047
• Device Sequence Number: 1
• Product Code: PEW
• UDI-Device Identifier: 00814932020001
• UDI-Public: 00814932020001
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K193269
• 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: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UL400
• Device Catalogue Number: AN00091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2020
• 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