BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEN INJ

    MDR report key: 7960431 · Received October 11, 2018

    Report

    Report Number
    MW5080519
    Event Type
    Injury
    Date Received
    October 11, 2018
    Report Date
    October 3, 2018
    Manufacturer
    ELI LILLY AND COMPANY PHARMACEUTICAL DELIVERY SYSTEMS
    Product Code
    FMF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT STATED A COUPLE OF THE NEEDLES SHE RECEIVED MALFUNCTIONED. SHE STATED 1 NEEDLE WAS BENT AND OTHER WAS SHORT BUT STILL WORKED. NO FURTHER DETAILS PROVIDED. THE EXACT THERAPY START DATE IS UNKNOWN, THE SHIPMENT MONTH HAS BEEN PROVIDED AS AN ESTIMATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796741 PEN INJ SYRINGE, PISTON FMF ELI LILLY AND COMPANY PHARMACEUTICAL DELIVERY SYSTEMS
    796742 PEN INJ SYRINGE, PISTON FMF ELI LILLY AND COMPANY PHARMACEUTICAL DELIVERY SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR