MAUDE Adverse Event Report: HUDSON RESPIRATORY CARE TECATE NEOTRACT UROLIFT SYSTEM

Model Number	UROLIFT SYSTEM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, neotract was made aware of a patient who received and successful prostatic urethral lift (pul) procedure on an unspecified date.It was reported that the patient was taking blood thinning medication, but had discontinued use during an unspecified time period for the pul procedure.The patient was advised by his cardiologist to resume the blood thinner sooner than desired by the physician who performed the procedure.As a result, the patient experienced excessive bleeding and an embolism, and was admitted to the hospital for three weeks post procedure.No further information is available for this patient despite multiple attempts contact the physician.

• Brand Name: NEOTRACT UROLIFT SYSTEM
• Common Device Name: UROLIFT SYSTEM
• Manufacturer (Section D): HUDSON RESPIRATORY CARE TECATE; prolongacion mision eusebio ki; no. 1316,rancho el descanso; tecate ; MX
• Manufacturer (Section G): HUDSON RESPIRATORY CARE TECATE; prolongacion mision eusebio ki; no. 1316,rancho el descanso; tecate ; MX
• Manufacturer Contact: brian gall ; 4155 hopyard rd.; pleasanton, CA 94588 ; 9253296547
• MDR Report Key: 15757477
• Report Number: 3015181082-2022-00041
• Device Sequence Number: 17685889
• Product Code: PEW
• UDI-Device Identifier: 10814932020275
• UDI-Public: 10814932020275
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K193269
• 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): 11/08/2022

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 SYSTEM
• Device Catalogue Number: IPN918876
• 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: 10/12/2022
• Initial Report FDA Received Date: 11/09/2022
• 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; Hospitalization
• Patient Sex: Male