BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UROLIFT

    MDR report key: 9920648 · Received April 3, 2020

    Report

    Report Number
    9920648
    Event Type
    Malfunction
    Date Received
    April 3, 2020
    Date of Event
    December 30, 2019
    Report Date
    March 12, 2020
    Manufacturer
    NEOTRACT, INC.
    Product Code
    PEW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DEVICE (NEOTRACT, INC. UROLIFT IMPLANTABLE TRANSPROSTATIC TISSUE RETRACTOR SYSTEM) MISFIRED, NO HARM TO PATIENT, NEW DEVICE OBTAINED, PROCEDURE CONTINUED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384386 UROLIFT IMPLANTABLE TRANSPROSTATIC TISSUE RETRACTOR SYSTEM PEW NEOTRACT, INC. 73K1900672

    Patients

    Seq Age Sex Outcome Treatment
    1 20075 DA