BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX

    MDR report key: 2140539 · Received June 21, 2011

    Report

    Report Number
    MW5021110
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    May 4, 2011
    Report Date
    June 21, 2011
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD A NEW MYNX CLOSURE DEVICE INSERTED AFTER PTCI PROCEDURE. PT LATER DEVELOPED A LARGE TOMATO SIZE HEMATOMA POST PROCEDURE, MANUAL PRESSURE WAS HELD TO SITE AND HEMATOMA WAS PRESSED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX MYNX CLOSURE DEVICE MGB ACCESSCLOSURE, INC. F1102505

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other