BEUDAMED
    FDA Adverse Event Death Summary report: N

    KIWI OMNICUP TRACTION FORCE

    MDR report key: 7495513 · Received May 8, 2018

    Report

    Report Number
    7495513
    Event Type
    Death
    Date Received
    May 8, 2018
    Date of Event
    April 26, 2018
    Report Date
    May 2, 2018
    Manufacturer
    CLINICAL INNOVATIONS
    Product Code
    HDB
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A 39 WEEK GESTATION WITH GROWTH RETARDATION EXPERIENCED DECELERATIONS DURING DELIVERY. VACUUM EXTRACTOR USED WITH 3 MINUTE TOTAL APPLICATION TIME, 2 PULLS AND NO INVOLUNTARY RELEASES. APPROX 1 HR AFTER DELIVERY DEVELOPED PALLOR, TACHYCARDIA AND INCREASING SCALP EXAM. IN SPITE OF RESUSCITATIVE EFFORTS, THE BABY DIED OF SUBGALEAL BLEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338761 KIWI OMNICUP TRACTION FORCE KIWI HDB CLINICAL INNOVATIONS VAC-6000MT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Death