BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CADD LEGACY

    MDR report key: 1040314 · Received May 8, 2008

    Report

    Report Number
    MW5006765
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    February 11, 2008
    Report Date
    May 7, 2008
    Manufacturer
    SMITHS MEDICAL
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CALL RECEIVED STATING PATIENT NOTED THAT THE INSIDE OF HER POUCH WAS WET. HUSBAND STATES THAT HE CAN SEE FLUID BETWEEN INNER BAG AND CASSETTE AND ALSO FLUID LEAKING ON OUTSIDE OF CASSETTE. HE HAS CHANGED OUT CASSETTE AND THIS ONE APPEARS TO BE RUNNING W/O PROBLEM. STATES WIFE IS HAVING NO SYMPTOMS. HUSBAND CONFIRMS PATIENT IS ON A RUNNING PUMP. HUSBAND STATES HE DOES HAVE THE PACKAGING AND CASSETTE AND LOT IS 266X17.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CADD LEGACY CADD MEDICATION RESERVOIR FPA SMITHS MEDICAL 266X17

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention