BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KOALA

    MDR report key: 441709 · Received February 7, 2003

    Report

    Report Number
    1722684-2003-00001
    Event Type
    Injury
    Date Received
    February 7, 2003
    Date of Event
    January 16, 2003
    Report Date
    February 6, 2003
    Manufacturer
    CLINICAL INNOVATIONS, INC.
    Product Code
    HGS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CO'S SALES REP, REPORTED THE FOLLOWING: IN 2003 AT 12:55 PM, DR. DETEMINED THAT IT WAS NECESSARY TO UTILIZE A KOALA IPC 5000C. UPON INSERTION, CLINICIANS NOTICED A LARGE AMOUNT OF BLOOD DRAINING FROM THE CATHETER AND NOTED AN INCREASE IN VAGINAL BLEEDING. RAPID ONSET OF FETAL BRADYCARDIA NECESSITATED THE DELIVERY OF THE INFANT VIA EMERGENCY CEASAREAN DELIVERY. APGAR SCORES WERE 0 AT 1 MINUTE, 0 AT 5 MINUTES. 20 MINUTES OF RESUSCITATIVE EFFORTS AND AN EMERGENCY TRANSFUSION WERE REQUIRED TO STABILIZE THE PT. UPON DELIVERY OF THE PLACENTA, A PERFORATION AT THE JUNCTION OF THE UMBILICAL CORD AND THE PLACENTA WAS OBSERVED. THE PHYSICIAN'S IMPRESSION IS THAT THE IUPC PUNCTURED THE UMBILICAL CORD. THE BABY WAS STABILIZED AND SENT TO HOSP. BABY WAS DISCHARGED 1 WEEK LATER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Life Threatening| R