BEUDAMED
    FDA Adverse Event Death Summary report: N

    KIWI OMNICUP TRACTION FORCE

    MDR report key: 16478724 · Received March 3, 2023

    Report

    Report Number
    MW5115410
    Event Type
    Death
    Date Received
    March 3, 2023
    Date of Event
    February 13, 2023
    Report Date
    March 1, 2023
    Manufacturer
    CLINICAL INNOVATIONS, LLC.
    Product Code
    HDB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    OPERATIVE VAGINAL DELIVERY VIA KIWI VACUUM. INFANT WITH SUBGALEAL BLEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1858257 KIWI OMNICUP TRACTION FORCE EXTRACTOR, VACUUM, FETAL HDB CLINICAL INNOVATIONS, LLC. VAC-6000MT

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Male Death