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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(4) 2022, neotract was made aware of a patient who received a successful prostatic urethral lift (pul) procedure on (b)(6) 2022.It was reported that three implants were not properly delivered.On (b)(6) 2022, it was further reported that the patient had to undergo plasma vaporization on (b)(6) 2022 to control bleeding and remove one implant.The patient was admitted for two days, but no additional interventions were required.It was reported that the patient was no longer experiencing adverse effects.

• Brand Name: NEOTRACT UROLIFT SYSTEM
• Common Device Name: UROLIFT SYSTEM
• Manufacturer (Section D): HUDSON RESPIRATORY CARE TECATE; prolongacion mision eusebio; kino no.1316,rancho el descano; tecate ; MX
• Manufacturer (Section G): HUDSON RESPIRATORY CARE TECATE; prolongacion mision eusebio; kinono.1316,rancho el descanso; tecate ; MX
• Manufacturer Contact: sriya bhupathiraju ; 4155 hopyard road; pleasanton, CA 94588 ; 9253106893
• MDR Report Key: 15114112
• Report Number: 3015181082-2022-00017
• Device Sequence Number: 5589531
• Product Code: PEW
• UDI-Device Identifier: 10814932020213
• UDI-Public: 10814932020213
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K193269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted 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): 07/27/2022

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: IPN919209
• Device Lot Number: 73A2200012
• 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: 06/30/2022
• Initial Report FDA Received Date: 07/27/2022
• 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
• Patient Sex: Male