BEUDAMED
    FDA Adverse Event Death Summary report: N

    KOALA INTRAUTERINE PRESSURE CATHETER

    MDR report key: 21048361 · Received December 31, 2024

    Report

    Report Number
    1722684-2024-00016
    Event Type
    Death
    Date Received
    December 31, 2024
    Date of Event
    August 29, 2022
    Report Date
    December 31, 2024
    Manufacturer
    CLINICAL INNOVATIONS LLC
    Product Code
    HFN
    UDI-DI
    00814247020178
    PMA / PMN Number
    K974389
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WE ARE INVESTIGATING THIS EVENT AND TRYING TO GATHER MORE INFORMATION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    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
    1752923 KOALA INTRAUTERINE PRESSURE CATHETER KOALA HFN CLINICAL INNOVATIONS LLC IPC-5000E UNKNOWN 00814247020178

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death