BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIEW FULL IMAGE KOALA INTRAUTERINE PRESSURE CATHETERS

    MDR report key: 20987650 · Received December 20, 2024

    Report

    Report Number
    MW5163779
    Event Type
    Death
    Date Received
    December 20, 2024
    Date of Event
    August 9, 2022
    Report Date
    December 19, 2024
    Manufacturer
    CLINICAL INNOVATIONS, LLC
    Product Code
    HFN
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    A LAWYER WHO REPRESENTED THE FAMILY CALLED TO SUBMIT A REPORT ABOUT A PEDIATRIC DEATH WITH THE USE OF KOALA'S INTRAUTERINE PRESSURE CATHETER. THE REPORTER STATED THE 27.6/7 GESTATION SUSTAIN 10.4 CM LACERATION ALL THE WAY DOWN TO HER SKULL WHILE SHE IS IN HIS MOTHER'S WOMB. MOM HAD PREMATURE RUPTURE OF MEMBRANES AND ADMITTED TO THE HOSPITAL, AND SHE DEVELOPED CHORIO. THE ATTENDING OB PHYSICIAN ORDERED IUPC, MULTIPLE INSERTION ATTEMPTS BY THE RESIDENT AND A FELLOW FAILED. MOM'S VAGINA WAS COVERED WITH FRANK BLOOD. THE BABY WAS DELIVERED BY CAESAREAN SECTION AT 11:50 PM IN (B)(6) HOSPITAL BY EMERGENCY C-SECTION. THE BABY WAS ADMITTED ON (B)(6) 2022 AND EXPIRED ON (B)(6) 2022. THE AUTOPSY DIAGNOSIS WAS BACTERIAL MENINGITIS. THE BABY WITH SCALPED AT THE TIME OF DELIVERY. THE BABY WAS DELIVERED 2 HOURS LATER, AND THE LACERATION WAS DISCOVERED. THE ULTRASOUND CONFIRMED THE INJURY OCCURRED WHILE BABY IS IN HIS MOTHER'S WOMB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2151433 VIEW FULL IMAGE KOALA INTRAUTERINE PRESSURE CATHETERS TRANSDUCER, PRESSURE, INTRAUTERINE HFN CLINICAL INNOVATIONS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 28 DA Female Death