BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KOALA

    MDR report key: 122722 · Received September 24, 1997

    Report

    Report Number
    MW1012169
    Event Type
    Injury
    Date Received
    September 24, 1997
    Date of Event
    September 14, 1997
    Report Date
    September 24, 1997
    Manufacturer
    CLINICAL INNOVATIONS, INC
    Product Code
    KXO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT IN EARLY LABOR WITH SROM. KOALA IUPC INSERTED BY MIDWIFE AT 1334 ON 9/14/97. CERVIX WAS 5 CM/90% EFFACEMENT, STATION 1. PT HAD 2 LATE DECELERATONS PRIOR TO INSERTION OF IUPC. LATE DECELS CONTINUED AFTER INSERTION OF IUPC. BLOOD RETURN NOTED WHEN IUPC PLACED. PLACENTAL ABRUPTION NOTED AT TIME OF CESARIAN. BABY BORN AT 1502.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KOALA IUPC INTRAUTERINE PRESSURE CATHETER KXO CLINICAL INNOVATIONS, INC * 970104

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Life Threatening| R