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

Model Number	UROLIFT SYSTEM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Urinary Retention (2119)
Date of Event	10/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021, neotract was made aware of a patient who received a successful prostatic urethral lift (pul) procedure on (b)(6) 2021.As a pre-procedural antibiotic, the patient was prescribed ancef.In the days following the procedure (timing unknown), the patient underwent emergency hemorrhoid surgery which urologist said was ¿unrelated to the pul procedure.¿ post hemorrhoid surgery, the patient experienced urinary retention.On (b)(6) 2021, he was admitted to the hospital for a c.Difficile infection, thought to be related to the ancef medication and not to the pul procedure.Ct imaging revealed air in his pelvis.Patient was transferred to the icu for two weeks for unknown reasons, has since been discharged and reported as doing well.The urologist stated that he believed the infection, urinary retention, and pelvic air were unrelated to the pul procedure.

• Brand Name: NEOTRACT UROLIFT SYSTEM
• Common Device Name: 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: 12849499
• Report Number: 3015181082-2021-00038
• Device Sequence Number: 4093859
• Product Code: PEW
• UDI-Device Identifier: 00814932020001
• UDI-Public: 00814932020001
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K193269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/19/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: UROLIFT SYSTEM
• Device Catalogue Number: UL400-4
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2021
• Initial Report FDA Received Date: 11/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male