BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 625733 · Received August 10, 2005

    Report

    Report Number
    6000030-2005-01231
    Event Type
    Injury
    Date Received
    August 10, 2005
    Report Date
    August 9, 2005
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE HCP REPORTED THE PATIENT WAS EXPERIENCING LOW BACK PAIN, HEADACHES, AND LEG STRIFFNESS AND CRAMPS AT NIGHT. THE HCP INCREASED THE BOLUS DOSE AND DECREASED THE "STEADY DOSE" SO THAT OVER 24 HOURS, THE OVER ALL DOSE WAS INCREASED BY 10%. THE PATIENT WAS SEEN ON 08/2005 FOR BACK PAIN, STIFFNESS, AND ITCHING. THE HCP PLANS TO DO A DYE STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL PUMP LKK RICE CREEK MANUFACTURING 8627L18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention