BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIWI VACUUM ASSISTED DELIVERY DEVICE

    MDR report key: 308907 · Received December 14, 2000

    Report

    Report Number
    1722684-2000-00002
    Event Type
    Injury
    Date Received
    December 14, 2000
    Date of Event
    November 11, 2000
    Report Date
    December 13, 2000
    Manufacturer
    CLINICAL INNOVATIONS, INC.
    Product Code
    HDB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    KIWI SILASTIC APPLIED WITH MOTHER CONSENT; AFTER NINE PULLS WITH KIWI WITH MOTHER PUSHING, CHILD DELIVERED. 5.5 CM LACERATION NOTED ON BABY'S HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIWI VACUUM ASSISTED DELIVERY DEVICE VACUUM DELIVERY CUP HDB CLINICAL INNOVATIONS, INC. VAC-6000M 000212

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention