BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX CADENCE

    MDR report key: 3121669 · Received April 19, 2013

    Report

    Report Number
    3121669
    Event Type
    Malfunction
    Date Received
    April 19, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 19, 2013
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING PREPARATION FOR DEPLOYMENT IT WAS NOTED THAT A SMALL AMOUNT OF COLLAGEN WAS ALREADY OUTSIDE OF THE PRODUCT HOUSING.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ULTRASOUND ASSISTED BILATERAL COMMON FEMORAL ARTERIAL PUNCTURES.BILATERAL COMMON ILIAC ARTERIAL STENTS.RIGHT EXTERNAL ILIAC ARTERIAL STENTING.BILATERAL MYNX CLOSURES OF COMMON FEMORAL ARTERIOTOMIES.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170197 MYNX CADENCE DEVICE, HEMOSTASIS, VASCULAR MGB ACCESSCLOSURE, INC. * F1233802

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR