BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEADER

    MDR report key: 2211490 · Received August 9, 2011

    Report

    Report Number
    MW5021711
    Event Type
    Injury
    Date Received
    August 9, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 9, 2011
    Manufacturer
    CARDINAL HEALTH
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    USING LEADER BRAND PRODUCT PEN NEEDLES, NEEDLES HAVE BENT GOING IN AND OUT OF SKIN AND ONE NEEDLE DID COME OFF IN SKIN. I REPORTED TO COMPANY WHO GAVE ME THE RUN AROUND BUT I FEEL THIS IS A MAJOR PROBLEM. DATES OF USE: (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEADER SHORT PEN NEEDLES 31 GAUGE X 5/16" .25MMX8MM FMI CARDINAL HEALTH 1010739.C065

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Disability