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 Code	Hematuria (2558)
Type of Reportable Event	Serious Injury
Event or Problem Description
On 17-november-2021, neotract was made aware of a published article which described a patient that underwent a prostatic urethral lift (pul) procedure on an unspecified date.It was reported that the patient experienced hematuria which required endoscopic hemostatic intervention.The details of the intervention were not specified, but it was reported the patient was hospitalized for three days.The current condition of the patient is unknown.
Event or Problem Description
On 17-november-2021, neotract was made aware of a published article which described a patient that underwent a prostatic urethral lift (pul) procedure on an unspecified date.It was reported that the patient experienced hematuria which required endoscopic hemostatic intervention.The details of the intervention were not specified, but it was reported the patient was hospitalized for three days.The current condition of the patient is unknown.

• 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: 13014656
• Report Number: 3015181082-2021-00041
• Device Sequence Number: 11924935
• Product Code: PEW
• UDI-Device Identifier: 00814932020001
• UDI-Public: 00814932020001
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K193269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/15/2021

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: AN00091
• 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: 11/17/2021
• Initial Report FDA Received Date: 12/15/2021
• 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: Required Intervention
• Patient Sex: Male