BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARTER¿ GUIDEWIRE

    MDR report key: 19078150 · Received April 10, 2024

    Report

    Report Number
    19078150
    Event Type
    Injury
    Date Received
    April 10, 2024
    Date of Event
    March 28, 2024
    Report Date
    April 1, 2024
    Manufacturer
    LAKE REGION MEDICAL LIMITED
    Product Code
    DQX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CONVERTING VA ECMO TO VV ECMO IN THE OR BY CARDIOTHORACIC SURGERY TEAM. TIP OF J CURVED WIRE REMOVED BY R IJ VENOGRAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412122 STARTER¿ GUIDEWIRE WIRE, GUIDE, CATHETER DQX LAKE REGION MEDICAL LIMITED M001491201

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other| R