BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KOALA

    MDR report key: 479439 · Received August 16, 2003

    Report

    Report Number
    1722684-2003-00002
    Event Type
    Injury
    Date Received
    August 16, 2003
    Date of Event
    July 12, 2003
    Report Date
    August 15, 2003
    Manufacturer
    CLINICAL INNOVATIONS, INC.
    Product Code
    HGS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    COMPANY'S SALES REPRESENTATIVE, REPORTED THE FOLLOWING: IN 2003 DR. (RESIDENT) USED A KOALA IUPC 5000E. DR. REPORTED THAT UPON INSERTION THERE WAS A BLOOD-TINGED FLASHBACK OF FLUID; HOWEVER, THE TRACINGS WERE FINE SO SHE ADVANCED THE CATHETER TO THE 45 CM MARK. APPROXIMATELY 5 MINUTES LATER DR. NOTICED A PROGRESSIVE DECELERATION AND A TRICKLE OF BLOOD FROM THE VAGINA. THE DECELERATION DID NOT RESPOND TO THE USUAL TREATMENT AND AN EMERGENT C-SECTION WAS CALLED. APGAR SCORES WERE 0 AT 1 MINUTE AND 0 AT 5 MINUTES. THE PT RECEIVED A BLOOD TRANSFUSION AND EXPERIENCED SEIZURES IN THE NICU. THE PT WAS DISCHARGED AFTER 14 DAYS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Hospitalization| R