BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTSTRING III PROXIMAL SEAL SYSTEM 40 3MM

    MDR report key: 3193571 · Received June 21, 2013

    Report

    Report Number
    MW5030680
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 21, 2013
    Manufacturer
    MAQUET GETINGE GROUP
    Product Code
    DXC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE SEAL APPEARED TO HAVE ADDITIONAL RINGS ON IT AND THE ANCHOR TAB WAS NOT SMOOTH. THEREFORE THE PROLENE SUTURES WERE CATCHING ON THAT CORD. ADDITIONAL SUTURES WERE NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282382 HEARTSTRING III PROXIMAL SEAL SYSTEM 40 3MM HEARTSTRING DXC MAQUET GETINGE GROUP HSK-3043 25067335

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention