BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT

    MDR report key: 494827 · Received November 4, 2003

    Report

    Report Number
    MW4003610
    Event Type
    Injury
    Date Received
    November 4, 2003
    Date of Event
    October 14, 2003
    Report Date
    October 27, 2003
    Manufacturer
    ABBOTT LABORATORIES INC
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2003 DAY OF SURGERY OF ORIF APPROX 32150 SPOUSE CAME OUT OF ROOM SAYING "SOMETHING IS WRONG". PT WAS CYANOTIC AND PULSELESS. ON PCA MORPHINE. PT HAD ALSO BEEN GIVEN PHENERGAN 12.5 MG IV FOR NAUSEA 35 MINS BEFORE OCCURRENCE. CODE CALLED, NARCAN 1.6MG GIVEN. INTUBATED-WEANED VENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT APM-II PUMP FRN ABBOTT LABORATORIES INC APM II *

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization MORPHINE SULFATE MANUFACTURED BY ABBOTT 2002.