BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIWI OMNI VACUUM DELIVERY SYSTEM

    MDR report key: 10825533 · Received November 11, 2020

    Report

    Report Number
    1722684-2020-00007
    Event Type
    Injury
    Date Received
    November 11, 2020
    Report Date
    November 11, 2020
    Manufacturer
    CLINICAL INNOVATIONS, LLC
    Product Code
    HDB
    PMA / PMN Number
    K981260
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INTRAPARENCHYMAL HEMORRHAGES, LIKE OTHER ICHS ARE VERY UNCOMMON. SEVERAL FACTORS HAVE BEEN SHOWN TO INCREASE THE RISK FOR SYMPTOMATIC ICH IN FULL-TERM NEWBORNS, INCLUDING PROLONGED, PRECIPITOUS, VAGINAL BREECH, INSTRUMENTAL, FORCEPS, OR VACUUM DELIVERY AS WELL AS PRIMIPARITY, HIGH MULTIPARITY, AND EXTREME FETAL WEIGHT. HOWEVER, IT IS IMPORTANT TO UNDERSTAND THAT ICH HAS ALSO BEEN REPORTED IN ASYMPTOMATIC TERM INFANTS. THE PREVALENCE WAS REPORTED AS LOW AS 8% AND HIGH AS TO 45.5% WHEN USING A 1.5-T MR IMAGER. CLINICAL INNOVATIONS HAS REQUESTED MORE INFORMATION FROM THE USER FACILITY ON THE INFANT'S OUTCOME, AND ANY OTHER DETAILS ON THE PROCEDURE. IF ANY ADDITIONAL INFORMATIONS IS OBTAINED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    CLINICAL INNOVATIONS RECEIVED, AND EMAIL FORM THE USER FACILITY WITH THE FOLLOWING QUESTION: ASK YOU ABOUT THE RISK OF INTRAPARENCHYMAL HEMORRHAGIC DISEASE AND KIWI. WE HAVE A CASE WITH NO PROBLEM WITH THE APPLICATION, USE OF THE KIWI, AND BAD RESULT IN THE NEONATAL PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1291554 KIWI OMNI VACUUM DELIVERY SYSTEM FETAL VACUUM EXTRACTOR HDB CLINICAL INNOVATIONS, LLC UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other