BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIWI VACUUM DELIVERY SYSTEM

    MDR report key: 10169156 · Received June 18, 2020

    Report

    Report Number
    1722684-2020-00006
    Event Type
    Injury
    Date Received
    June 18, 2020
    Date of Event
    March 5, 2020
    Report Date
    June 11, 2020
    Manufacturer
    CLINICAL INNOVATIONS, LLC
    Product Code
    HDB
    UDI-DI
    00814247020000
    PMA / PMN Number
    K981260
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CEPHALOHEMATOMAS ARE A KNOWN RISK FACTOR FOR VACUUMS DELIVERIES. AS THE DEVICE WAS DISCARDED WE ARE UNABLE TO EVALUATE THE PRODUCT AND DETERMINE HOW THE USE OF THE PRODUCT COULD HAVE CONTRIBUTED TO THE INJURY. IT WAS REPORTED THAT THE INFANT APPEARS TO NOT HAVE ANY LONG-TERM DEFICIENCIES OR SEQUELAE. CLINICAL INNOVATIONS WILL CONTINUE TO MONITOR THE EVENT AND PROVIDE ANY ADDITIONAL DATA IF IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    A PREGNANT WOMAN FACING THE PROBLEM OF THREATENED PREMATURE DELIVERY STARTED LABOR AT A GESTATIONAL AGE OF 36 WEEKS. TO COPE WITH THE NRFS (NON REASSURING FETAL STATUS), HER BABY WAS SUBJECT TO SUCTION-DELIVERY WITH THE KIWI OMNI CUP. WHILE THE CUP WAS APPLIED TO THE RIGHT SIDE FROM THE BENDING POINT DUE TO AN ANOMALY OF ROTATION, SUCTIONING WAS SUCCESSFUL WITHOUT ANY SLIPPAGE AT THE 1ST ATTEMPT, THE BABY WEIGHING (B)(6) G, HOWEVER, WAS FOUND TO HAVE CEPHALHEMATOMA. SINCE IT GREW BIGGER IN A FEW DAYS, THE BABY GOT A CT AND WAS FOUND TO SUFFER A FRACTURED SKULL IN 3 PLACES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630108 KIWI VACUUM DELIVERY SYSTEM FETAL VACUUM EXTRACTOR HDB CLINICAL INNOVATIONS, LLC VAC-6000M 191028 00814247020000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other