BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIWI OMNICUP VACUUM

    MDR report key: 2140530 · Received June 21, 2011

    Report

    Report Number
    MW5021102
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    May 29, 2011
    Report Date
    June 21, 2011
    Manufacturer
    CLINICAL INNOVATIONS
    Product Code
    HDB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TERM PREGNANT LABORING PT PUSHING. PHYSICIAN APPLIED THE VACUUM AND THE VACUUM DELIVERY FAILED. BABY WAS DELIVERED BY CESAREAN SECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIWI OMNICUP VACUUM VACUUM HDB CLINICAL INNOVATIONS 110208

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Disability