BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KOALA

    MDR report key: 485453 · Received September 22, 2003

    Report

    Report Number
    1722684-2003-00003
    Event Type
    Injury
    Date Received
    September 22, 2003
    Date of Event
    September 1, 2003
    Report Date
    September 17, 2003
    Manufacturer
    CLINICAL INNOVATIONS, INC.
    Product Code
    HGS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2003, DR. USED A KOALA IUPC 5000E. DR. REPORTED THAT THERE WAS BLOOD RETURN AFTER PLACEMENT AND WAS FOLLOWED BY FETAL BRADYCARDIA. AN EMERGENT C-SECTION WAS CALLED. APGAR SCORES WERE 0 AT 1 MINUTE AND 0 AT 5 MINUTES. THE BABY WAS REVIVED AND TRANSFERRED TO ANOTHER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KOALA INTRAUTERINE PRESSURE CATHETER HGS CLINICAL INNOVATIONS, INC. IPC-5000E 020502

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Hospitalization