BEUDAMED
    FDA Adverse Event Summary report: N

    KIWI VACUUM DELIVERY SYSTEM

    MDR report key: 1666125 · Received April 1, 2010

    Report

    Report Number
    1666125
    Date Received
    April 1, 2010
    Date of Event
    March 30, 2010
    Report Date
    April 1, 2010
    Manufacturer
    CLINICAL INNOVATIONS, LLC
    Product Code
    HDB
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    VACUUM FAILED TO ATTACH CORRECTLY AFTER FOUR ATTEMPTS. PHYSICIAN USING VACUUM TO ASSIST IN DELIVERY OF FETAL HEAD DURING C-SECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIWI VACUUM DELIVERY SYSTEM EXCTRACTOR, VACUUM, FETAL HDB CLINICAL INNOVATIONS, LLC * 091371 N

    Patients

    Seq Age Sex Outcome Treatment
    1 *