BEUDAMED
    FDA Adverse Event Other Summary report: N

    KIWI COMPLETE VACUUM DELIVERY SYSTEMS

    MDR report key: 517583 · Received March 22, 2004

    Report

    Report Number
    517583
    Event Type
    Other
    Date Received
    March 22, 2004
    Date of Event
    March 9, 2004
    Report Date
    March 17, 2004
    Manufacturer
    CLINICAL INNOVATIONS, INC.
    Product Code
    HDB
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFANT DELIVERED VIA VACUUM EXTRACTION (KIWI VACUUM) AND INFANT HAD A LACERATION, SUBGALEAL HEMATOMA AND SKULL FRACTURE (POSSIBLY FROM FORCEPS DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIWI COMPLETE VACUUM DELIVERY SYSTEMS VACUUM DELIVERY DEVICE HDB CLINICAL INNOVATIONS, INC. * 040116

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Other