BEUDAMED
    FDA Adverse Event Death Summary report: N

    KIWI COMPLETE VACUUM DELIVERY SYSTEM

    MDR report key: 435901 · Received January 3, 2003

    Report

    Report Number
    435901
    Event Type
    Death
    Date Received
    January 3, 2003
    Date of Event
    December 24, 2002
    Report Date
    January 2, 2003
    Manufacturer
    CLINICAL INNOVATIONS, INC.
    Product Code
    HDB
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT BRAIN-DAMAGED AND ULTIMATELY EXPIRED AFTER DELIVERY USING VACUUM. UNSURE IF PRODUCT DEFECT OR USER ERROR. ORIGINAL DEVICE WAS DISCARDED. LOT NUMBER UNKNOWN, BUT COULD POSSIBLY BE #020445.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIWI COMPLETE VACUUM DELIVERY SYSTEM VACUUM DELIVERY DEVICE HDB CLINICAL INNOVATIONS, INC. * POSSIBLY #020445

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Death