BEUDAMED
    FDA Adverse Event Other Summary report: N

    KIWI COMPLETE VACUUM DELIVERY SYSTEMS

    MDR report key: 502777 · Received December 22, 2003

    Report

    Report Number
    502777
    Event Type
    Other
    Date Received
    December 22, 2003
    Date of Event
    November 20, 2003
    Report Date
    December 16, 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

    MOST LIKELY USER ERROR OF KIWI VACUUM EXTRACTION DEVICE. ORIGINAL DEVICE DISCARDED. LOT NUMBER UNKNOWN, BUT MOST LIKELY #030718. PT IS OKAY AND SUFFERED SUPERFICIAL HEMATOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIWI COMPLETE VACUUM DELIVERY SYSTEMS VACUUM DELIVERY DEVICE HDB CLINICAL INNOVATIONS, INC. * POSSIBLY #030718

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Other