BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UROLIFT SYSTEM

    MDR report key: 16246920 · Received January 25, 2023

    Report

    Report Number
    MW5114506
    Event Type
    Malfunction
    Date Received
    January 25, 2023
    Date of Event
    January 18, 2023
    Report Date
    January 23, 2023
    Manufacturer
    NEOTRACT, INC.
    Product Code
    PEW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    UROLIFT SYSTEM STRING BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485361 UROLIFT SYSTEM IMPLANTABLE TRANSPROSTATIC TISSUE RETRACTOR SYSTEM PEW NEOTRACT, INC. UL400-4 73A2200671

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown