BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK

    MDR report key: 805765 · Received January 19, 2007

    Report

    Report Number
    MW1041657
    Event Type
    Death
    Date Received
    January 19, 2007
    Date of Event
    September 7, 2006
    Manufacturer
    UNK
    Product Code
    HDA
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    REPORTER IS MOTHER WHO STATES THAT INFANT SUFFERED A HEAD INJURY AND SUBDURAL HEMATOMA AT BIRTH FROM VAGINAL DELIVERY AT A HOSP. ONE MONTH PRIOR TO DELIVERY, MOTHER STATES THAT SHE WAS HOSPITALIZED BECAUSE HER WATER BROKE EARLY. SHE WAS PRESCRIBED STEROIDS, MAGNESIUM, AND OTHER LABOR STOPPING TREATMENT. WHEN THE MOTHER'S LABOR DID OCCUR, SHE HAD TO TELL STAFF TO PLACE MONITOR ON HER. SHE DIDN'T SEE THE FORCEPS OR VACUUM, BUT SHE DEFINITELY FELT THE FORCEPS PRESSURE. HER CHILD WAS BORN WITH A LARGE BRUISE TO THE BACK OF HIS HEAD AND BEHIND BOTH EARS. SUBSEQUENTLY, HE SUFFERED A MAJOR BRAIN INJURY AND DEVELOPED LOTS OF FLUID ON THE BRAIN, MAKING IT IMPOSSIBLE FOR HIS BRAIN TO DEVELOP. MOM IS NOW SEEKING ANSWERS. THIS WAS HER 2ND CHILD. HER FIRST CHILD WAS PREMATURE, BUT DIDN'T HAVE ANY HEAD OR BRAIN PROBLEMS. THIS DELIVERY WAS PREMATURE. THE HOSPITAL EQUATES THE HEAD INJURY TO THE MOTHER'S CERVIX, BUT REPORTER STATES SHE FELT THE PRESSURE OF THE FORCEPS AND KNOWS THAT THIS CONTRIBUTED TO THE DAMAGES THAT HER BABY SUFFERED. INFANT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK MANUAL FORCEPS HDA UNK * *

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Death