BEUDAMED
    FDA Adverse Event Death Summary report: N

    SURGILENE 4-0 CV-307 DA 90CMX36

    MDR report key: 328191 · Received April 20, 2001

    Report

    Report Number
    2648188-2001-00010
    Event Type
    Death
    Date Received
    April 20, 2001
    Date of Event
    March 22, 2001
    Report Date
    March 23, 2001
    Manufacturer
    KENDALL HEALTHCARE PRODUCTS COMPA
    Product Code
    GAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PRODUCT WAS USED DURING A VALVE REPLACEMENT. REPORTEDLY, SIX HOURS POST-OPERATIVELY, THE PT WAS SAT UP TO EXTUBATE. BLOOD STARTED TO DRAIN INTO THE CHEST TUBES AND THE PT'S CONDITION DETERIORATED. THE INCISION WAS RE-OPENED IN THE ROOM AND THE SURGEON COULD NOT GET ACCESS TO THE BLEEDING. RESUSCITATION WAS UNSUCCESSFUL AND THE PT EXPIRED.

    Description of Event or Problem · 1

    A WARM AUTOPSY WAS DONE BY THE SURGEON. HIS FINDINGS WERE THE SURROUNDING TISSUE WAS INTACT, NO PULL THROUGH OF THE SUTURE SEEN. IT APPEARED THAT THE SUTURE BROKE AWAY FROM THE KNOT. ALSO, AS THE STAFF WAS REMOVING THE TOWELS FROM THE WOUND(IN THE CV-ICU), A PIECE OF SUTURE WAS FOUND ON ONE OF THE TOWELS AND DISCARDED. FURTHER INFORMATION WAS OBTAINED FROM THE OPERATING ROOM DIRECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18413 SURGILENE 4-0 CV-307 DA 90CMX36 SUTURE GAW KENDALL HEALTHCARE PRODUCTS COMPA NA 4000066443

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death