BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMAPEN EROG, BURGUNDY/CLEAR

    MDR report key: 1070626 · Received June 30, 2008

    Report

    Report Number
    1819470-2008-00035
    Event Type
    Malfunction
    Date Received
    June 30, 2008
    Report Date
    June 5, 2008
    Manufacturer
    ELI LILLY AND CO.
    Product Code
    FMF
    PMA / PMN Number
    K982842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTABLE MALFUNCTION/NEAR INCIDENT IDENTIFIED. INVESTIGATION IN PROGRESS. NOTE: THIS IS AN INITIAL REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE FINAL EVAL IS COMPLETED.

    Description of Event or Problem · 1

    THIS DEVICE CASE, WHICH DOES NOT INVOLVE AN ADVERSE EVENT, REPORTED BY A CONSUMER, WHO CONTACTED THE COMPANY WITH A PRODUCT COMPLAINT, CONCERNS A MALE PT OF UNK ORIGIN. THE PT WAS TAKING AN UNSPECIFIED MEDICATION FOR TREATMENT OF AN UNK INDICATION. IN 2008, THE HUMAPEN ERGO BURGUNDY/CLEAR PEN BODY (LOT 0404A04) WITH A CLEAR CARTRIDGE HOLDER ATTACHED WAS REPORTED TO HAVE TWO BROKEN ENGAGEMENT TABS. THIS HUMAPEN ERGO, BURGUNDY/CLEAR IS ASSOCIATED WITH ANOTHER DEVICE. THE OPERATOR OF THE DEVICE WAS UNK AND IT WAS UNK IF THE OPERATOR OF THE DEVICE WAS TRAINED. IT WAS UNK HOW LONG THE PT HAD USED THIS DEVICE MODEL. THE DEVICE WAS RETURNED TO THE COMPANY ON 09-JUN-2008. INITIAL EXAMINATION FOUND TWO BROKEN ENGAGEMENT TABS. IT WAS UNK IF THIS HUMAPEN ERGO, BURGUNDY/CLEAR WAS CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN EROG, BURGUNDY/CLEAR PEN INJECTOR FOR TREATMENT PURPOSES FMF ELI LILLY AND CO. MS8930 0404A04

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR