BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6 FR FISH CLOSURE DEVICE

    MDR report key: 9490960 · Received December 17, 2019

    Report

    Report Number
    MW5091731
    Event Type
    Malfunction
    Date Received
    December 17, 2019
    Date of Event
    December 9, 2019
    Report Date
    December 13, 2019
    Manufacturer
    MORRIS INNOVATIVE RESEARCH, INC.
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    OPENED FISH CLOSURE DEVICE AND THE DISTAL TIP OF DILATOR WAS WARPED AND FRAYED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1278358 6 FR FISH CLOSURE DEVICE DEVICE, HEMOSTASIS, VASCULAR MGB MORRIS INNOVATIVE RESEARCH, INC. 6408

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR