BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT

    MDR report key: 494829 · Received November 4, 2003

    Report

    Report Number
    MW4003611
    Event Type
    Injury
    Date Received
    November 4, 2003
    Date of Event
    February 22, 2003
    Report Date
    October 27, 2003
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    "PT WAS DAY 1 POST OP FROM A RIGHT COLECTOMY. HAD A FENTANYL EPIDURAL AT 10MCG/ML. FOUND AT 0710 WITH AN O2 SATURATION OF 40% AND NON-RESPONSIVE. CODE CALLED. NARCAN 1MG GIVEN IV. RESPONDED TO NARCAN."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention FENTANYL MANUFACTURED BY ABBOTT.