BEUDAMED
    FDA Adverse Event Death Summary report: N

    ATRAAUCLIP

    MDR report key: 22618 · Received January 30, 1995

    Report

    Report Number
    1044475-1994-00001
    Event Type
    Death
    Date Received
    January 30, 1995
    Date of Event
    November 10, 1994
    Report Date
    December 5, 1994
    Manufacturer
    SPK TECHNOLOGY, INC.
    Product Code
    GDO
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE HOSPITAL NOTIFIED THE SALES REPRESENTATIVE ON 11/30/94.SUREON CLIPPED OFF BRANCH OF PULMONARY ARTERY DURING A THORACOTOMY ON 11/10/94. SEVERAL HRS AFTER SURGERY, PT HAD A MASSIVE HEMORRHAGING AND EXPIRED AT 12:01 A.M., 11/11/94. ONE CLIP WAS USED AND ALSO TIED WITH SUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATRAAUCLIP Implant LIGATING CLIP GDO SPK TECHNOLOGY, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death