BEUDAMED
    FDA Adverse Event Death Summary report: N

    KIWI OMNICUP TRACTION FORCE

    MDR report key: 7529692 · Received May 21, 2018

    Report

    Report Number
    MW5077327
    Event Type
    Death
    Date Received
    May 21, 2018
    Date of Event
    October 26, 2017
    Report Date
    May 17, 2018
    Manufacturer
    CLINICAL INNOVATIONS LLC
    Product Code
    HDB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SUBGALEAL HEMORRHAGE. FAILED VACUUM DELIVERY RESULTING IN C-SECTION DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373137 KIWI OMNICUP TRACTION FORCE EXTRACTOR, VACUUM, FETAL HDB CLINICAL INNOVATIONS LLC VAC-6000MT

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Death