BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMAPEN ERGO TEAL/CLEAR

    MDR report key: 1525218 · Received November 12, 2009

    Report

    Report Number
    1819470-2009-00060
    Event Type
    Malfunction
    Date Received
    November 12, 2009
    Report Date
    October 16, 2009
    Manufacturer
    ELI LILLY AND COMPANY
    Product Code
    NSC
    PMA / PMN Number
    K982842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT SUGGESTIVE OF REPORTABLE MALFUNCTION/NEAR INCIDENT. WILL INVESTIGATE FURTHER. THIS IS AN INITIAL REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE FINAL EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    (B)(4). THIS DEVICE CASE, WHICH DOES NOT INVOLVE AN ADVERSE EVENT, REPORTED BY A CONSUMER, WHO CONTACTED THE COMPANY WITH A PRODUCT COMPLAINT, CONCERNS A FEMALE PATIENT OF UNKNOWN AGE AND ORIGIN. THE PATIENT WAS TAKING AN UNSPECIFIED MEDICATION FOR THE TREATMENT OF AN UNKNOWN INDICATION. ON (B)(6) 2009, THE HUMAPEN ERGO TEAL/CLEAR PEN BODY WITH A CLEAR CARTRIDGE HOLDER ATTACHED (LOT 0504A01) WAS REPORTED TO BE WITH THE ENGAGEMENT TABS DAMAGED. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT ALWAYS REUSED THE NEEDLES. THIS HUMAPEN ERGO TEAL/CLEAR PEN BODY WITH A CLEAR CARTRIDGE HOLDER ATTACHED IS ASSOCIATED WITH PC 1071467. IT WAS NOT SPECIFIED WHO OPERATED THE DEVICE BUT THE OPERATOR WAS SELF-TRAINED BY USING THE USER MANUAL. THE REPORTED DEVICE HAD BEEN USED FOR THREE YEARS (SINCE 2006) BUT IT WAS UNKNOWN HOW LONG THIS DEVICE MODEL HAD BEEN USED. THE DEVICE WILL BE RETURNED AND EVALUATION WILL BE PERFORMED TO VERIFY IF A MALFUNCTION OCCURRED. IT WAS UNKNOWN IF THE HUMAPEN ERGO TEAL/CLEAR PEN BODY WITH A CLEAR CARTRIDGE HOLDER ATTACHED WAS CONTINUED OR SWITCHED TO A NEW DEVICE OR SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN ERGO TEAL/CLEAR PEN INJECTOR FOR TREATMENT PURPOSES NSC ELI LILLY AND COMPANY MS8929 0504A01

    Patients

    Seq Age Sex Outcome Treatment
    1