BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITY VAC II

    MDR report key: 1033411 · Received April 22, 2008

    Report

    Report Number
    MW5006386
    Event Type
    Injury
    Date Received
    April 22, 2008
    Date of Event
    April 9, 2008
    Report Date
    April 22, 2008
    Product Code
    HDB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE BABY WAS IN AN OCCIPUT POSTERIOR POSITION. MOTHER WAS ADAMANTLY OPPOSED TO A CESAREAN. SHE PUSHED SEVERAL MORE TIMES AND THE VERTEX WAS AT +2 STATION. AGAIN WE DISCUSSED OPTIONS AND SHE AGAIN ADAMANTLY DID NOT WANT A CESAREAN. THEREFORE, MITYVAC EXTRACTOR WAS PLACED TO THE CROWN, AND THROUGH THREE SEPARATE CONTRACTIONS. I WAS ABLE TO AFFECT DELIVERY OF THE VERTEX. SUBGALEAL HEMATOMA: A MASS WAS NOTED OVER THE RIGHT OCCIPITAL AREA AND EXTENDING DOWN THE NEXT TO THE LEVEL OF THE SHOULDERS. THIS AREA IS FLUCTUANT WITH DARK DISCOLORATION OF THE SKIN OVER THE AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MITY VAC II MITY VAC HDB

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Hospitalization