BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT MEDICAL INQ WIRE

    MDR report key: 15028554 · Received July 14, 2022

    Report

    Report Number
    MW5110891
    Event Type
    Malfunction
    Date Received
    July 14, 2022
    Date of Event
    June 9, 2022
    Report Date
    July 13, 2022
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MERIT MEDICAL INQ WIRE LOT # K2261945 -GUIDEWIRE BROKE AND INNER CORE WAS EXPOSED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1057610 MERIT MEDICAL INQ WIRE WIRE, GUIDE, CATHETER DQX MERIT MEDICAL SYSTEMS, INC. K2261945

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown