MAUDE Adverse Event Report: NEOTRACT, INC. NEOTRACT UROLIFT 2 SYSTEM

Model Number	UROLIFT 2 SYSTEM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	04/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On 20 april 2022, neotract was notified about a patient who received a successful prostatic urethral lift (pul) procedure on an unspecified date.After the procedure, the patient presented with bruising on the pelvis, scrotum, and penis.On 25 april 2022, it was reported that during a visit to the urologist on (b)(6) 2022 the hematoma was resolving on its own and did not require intervention.On 13 june 2022 it was reported that the remaining hematoma was drained (b)(6) 2022.The patient was reported as doing fine with expected irritation from the procedure and continued improvement.

• Brand Name: NEOTRACT UROLIFT 2 SYSTEM
• Common Device Name: UROLIFT 2 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: sriya bhupathiraju ; 4155 hopyard road; pleasanton, CA 94588 ; 9253106893
• MDR Report Key: 14983146
• Report Number: 3015181082-2022-00013
• Device Sequence Number: 5022178
• Product Code: PEW
• UDI-Device Identifier: 10814932020121
• UDI-Public: 10814932020121
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K201837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 07/11/2022

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 2 SYSTEM
• Device Catalogue Number: IPN056134
• Device Lot Number: P01333
• 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: 06/13/2022
• Initial Report FDA Received Date: 07/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 60 YR
• Patient Sex: Male