BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT

    MDR report key: 753021 · Received June 17, 2005

    Report

    Report Number
    MW1035756
    Event Type
    Other
    Date Received
    June 17, 2005
    Date of Event
    April 25, 2005
    Report Date
    May 3, 2005
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNABLE TO RECEIVE COMPLETE BOLUS OF PAIN MEDICATION. EVERYTIME PENDANT PUSHED ONLY PARTIAL DOSE DELIVERED BEFORE PUMP READS "OCCLUSION." THE CO (HOSPIRA) IS AWARE OF PROBLEMS WITH THIS PRODUCT. THE PRODUCT WAS ALLEGEDLY RECALLED LAST YEAR - HOWEVER , WE DID NOT RECIEVE ANY NOTICE OF RECALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT VIAL FMF ABBOTT LABORATORIES * 16-147-DK
    2 HOSPIRA PCA PUMP MEA ABBOTT LABORATORIES PCA3 *

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other