BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEEDLE

    MDR report key: 7952088 · Received October 9, 2018

    Report

    Report Number
    MW5080450
    Event Type
    Injury
    Date Received
    October 9, 2018
    Date of Event
    September 5, 2018
    Manufacturer
    UNK
    Product Code
    FMI
    UDI-DI
    08489830910
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PEN NEEDLES ARE NOT WORKING BY NOT PUSHING DOWN CORRECTLY WITH INSULIN DETEMIR FLEXTOUCH PEN. PEN NEEDLE NDC 08489-8309-10. LOT # X56ZC9. PEN NEEDLES NOT PUSHING DOWN CORRECTLY IN INSULIN PEN. TREATMENT DRUGS USED: INSULIN DOSE: ROUTE: SQ DATES OF USE: (B)(6) 2015 THRU N/A. DIAGNOSIS FOR USE: DIABETES MELLITUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791078 NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI UNK X56ZC9 08489830910

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other