BEUDAMED
    FDA Adverse Event Death Summary report: N

    MITYVAC

    MDR report key: 487098 · Received September 29, 2003

    Report

    Report Number
    1216677-2003-00015
    Event Type
    Death
    Date Received
    September 29, 2003
    Date of Event
    July 9, 2003
    Report Date
    September 29, 2003
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HDB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AFTER AN EXTENDED BIRTHING PROCESS, THE DEVICE WAS APPLIED AND UTILIZED TO FACILITATE DELIVERY. PT PRESENTED WITH VERY LOW HEART RATE. ATTEMPTS TO REVITALIZE THE PT WERE NOT SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MITYVAC FETAL VACUUM EXTRACTOR HDB COOPERSURGICAL, INC. 10022 I9411

    Patients

    Seq Age Sex Outcome Treatment
    1 Death