BEUDAMED
    FDA Adverse Event Death Summary report: N

    *

    MDR report key: 1047493 · Received May 19, 2008

    Report

    Report Number
    1722684-2008-00005
    Event Type
    Death
    Date Received
    May 19, 2008
    Manufacturer
    CLINICAL INNOVATIONS, LLC
    Product Code
    HDB
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DIRECTOR OF CLINICAL INNOVATIONS, SPOKE WITH THE RISK MGR REGARDING THIS EVENT. THERE WERE 12-14 POPOFFS ASSOCIATED WITH THE DELIVERY WHICH IS CONTRARY TO OUR GUIDELINES. THE BABY SUFFERED AN ANOXIC EVENT MAKING THE BABY A BAD CANDIDATE FOR VACUMM IN THE FIRST PLACE AND PROBABLY SHOULD HAVE UNDERGONE A CESAREAN SECTION IN THE FIRST PLACE. THE RISK MGR AGREED THIS WAS A CASE OF USER-ERROR AND HAD NOTHING TO DO WITH THE DEVICE ITSELF. THERE IS NO EVIDENCE THAT THE KIWI VACUUM DEVICE MALFUNCTIONED IN ANY WAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * HDB CLINICAL INNOVATIONS, LLC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *