BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMAPEN ERGO, TEAL/OPAQUE

    MDR report key: 1193522 · Received October 8, 2008

    Report

    Report Number
    1819470-2008-00052
    Event Type
    Malfunction
    Date Received
    October 8, 2008
    Report Date
    September 11, 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 EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    THIS DEVICE CASE, WHICH DOES NOT INVOLVE AN ADVERSE EVENT, REPORTED BY A SALES REP, WHO CONTACTED THE COMPANY WITH A PRODUCT COMPLAINT, CONCERNS A PATIENT OF UNK GENDER, AGE AND ORIGIN. THE PT WAS TAKING AN UNSPECIFIED MEDICATION FOR TREATMENT OF AN UNKNOWN INDICATION. IN 2008, THE HUMAPEN ERGO TEAL/OPAQUE PEN BODY (LOT NR A1441) WITH A CLEAR CARTRIDGE HOLDER ATTACHED WAS REPORTED TO HAVE A JAMMED PLUNGER AND HIGH INJECTION FORCE WAS REQUIRED. THIS HUMAPEN ERGO, TEAL/OPAQUE PEN BODY WITH A CLEAR CARTRIDGE HOLDER ATTACHED IS ASSOCIATED WITH 673823. 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 AT ABOUT THREE DAYS LATER. INITIAL EXAMINATION FOUND TWO BROKEN ENGAGEMENT TABS. IT WAS UNK IT THIS HUMAPEN ERGO TEAL/OPAQUE PEN BODY WITH CLEAR CARTRIDGE HOLDER ATTACHED WAS CONTINUED. UPDATE 06-OCT-2008; ADDITIONAL INFO RECEIVED 03-OCT-2008; ADDED LOT NUMBER TO CASE AND RECODED DEVICE FROM HUMAPEN ERGO TEAL/CLEAR TO TEAL/OPAQUE PEN BODY. UPDATED CORRESPONDING FIELD, NARRATIVE AND PSUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN ERGO, TEAL/OPAQUE PEN INJECTOR FOR TREATMENT PURPOSES FMF ELI LILLY AND CO. MS8335 A1441

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK