BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BEHRING FIBRINTIMER A

    MDR report key: 129668 · Received July 1, 1997

    Report

    Report Number
    129668
    Event Type
    Injury
    Date Received
    July 1, 1997
    Date of Event
    May 19, 1996
    Report Date
    June 18, 1996
    Manufacturer
    BEHRING DIAGNOSTIC, INC.
    Product Code
    GKT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED TO HOSP FOR ABDOMINAL PAIN ON 5/18/96. BECAUSE OF SEVERE PAIN CT OF ABDOMEN DONE AND REVEALED PORTAL VEIN THROMBOSIS INVOLVING THE SPLENIC AND SUPERIOR MESENTERIC VEINS. PT WAS STARTED ON HEPARIN AND TPA (TISSUE PLASMINOGEN ACTIVATOR). LABS DRAWN 5/19/96 1814 FOR PTT WERE REPORTED BACK AT 7160. DUE TO THIS, PT'S HEPARIN WAS STOPPED, TPA CONTINUED. WHEN CORRECTED LAB VALUE REPORTED, THE HEPARIN WAS RESTARTED AT A HIGHER DOSE. PT WAS DISCHARGED 6/3/96.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BEHRING FIBRINTIMER A COAGULATION INSTRUMENT GKT BEHRING DIAGNOSTIC, INC. * *
    2 REAGENT PATHROMPTIN REAGENT GIT BEHRING DIAGNOSTIC, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Life Threatening| R