BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITYVAC MYSTIC II M-STYLE MUSHROOM CUP VACUUM ASSISTED

    MDR report key: 1964017 · Received January 11, 2011

    Report

    Report Number
    MW5019028
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 11, 2011
    Manufacturer
    COOPER SURGICAL
    Product Code
    HDB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INFANT WITH RIGHT PARIETAL AND MILD LEFT PARIETAL BONE FRACTURES. MODERATE SIZE RIGHT FRONTAL PARIETAL CEPHALOHEMATOMA AND SMALL PARAFALCINE ACUTE SUBDURAL HEMATOMA WITHOUT MASS EFFECT - POST VACUUM EXTRACTION DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MITYVAC MYSTIC II M-STYLE MUSHROOM CUP VACUUM ASSISTED MYTYVAC HDB COOPER SURGICAL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Hospitalization