BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMAPEN ERGO, TEAL, OPAQUE

    MDR report key: 618120 · Received June 3, 2005

    Report

    Report Number
    1819470-2005-00009
    Event Type
    Malfunction
    Date Received
    June 3, 2005
    Report Date
    May 4, 2005
    Manufacturer
    ELI LILLY AND CO.
    Product Code
    KZE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS TAKING UNSPECIFIED INSULIN UNKNOWN FORMULATION VIA A PEN INJECTION DEVICE (HUMAPEN ERGO.) CLEAR CARTRIDGE HOLDER - CCH, ATTACHED LOTA1415) FOR DIABETES MELLITUS. THE PERSON OPERATION THE DEVICE WAS THE PATIENT- IT IS UNKNOWN IF THE OPERATOR OF THE DEVICE WAS TRAINED. THE PLASTIC IS BROKEN/CRACKED IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN ERGO, TEAL, OPAQUE PEN INJECTOR KZE ELI LILLY AND CO. MS8225 A1415

    Patients

    Seq Age Sex Outcome Treatment
    1 *