BEUDAMED
    FDA Adverse Event Death Summary report: N

    KOALA

    MDR report key: 990625 · Received January 28, 2008

    Report

    Report Number
    MW5005143
    Event Type
    Death
    Date Received
    January 28, 2008
    Date of Event
    January 4, 2008
    Report Date
    January 28, 2008
    Manufacturer
    CLINICAL INNOVATIONS, INC.
    Product Code
    HGS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WE HAVE SUSPICION TO BELIEVE THAT THE PLACEMENT OF AN INTRAUTERINE PRESSURE SYSTEM CATHETER MAY HAVE CAUSED A PERFORATION OF THE PLACENTA OR UMBILICAL CORD. AT APPROX. 2120 IUPC WAS INSERTED BY A PHYSICIAN WITH NO FLASH BACK. BETWEEN 2124-2133, THE FETAL HEART RATE INCREASED TO 190 OVER 4 MINUTES AND THEN DECREASED TO 60 OVER 5 MINUTES. THE DECISION WAS MADE TO PEFORM A C-SECTION. AT 2131, THE IUPC WAS REMOVED. VAGINAL EXAM SHOWED RETURN OF BLOOD AND CLOTS. THE BABY WAS EMERGENTLY REMOVED AND RESUSCITATION WAS UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KOALA INTRAUTERINE PRESSURE CATHETER HGS CLINICAL INNOVATIONS, INC. IPC 5000

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Death