BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEN NEEDLE

    MDR report key: 3142471 · Received March 22, 2013

    Report

    Report Number
    2243072-2013-00015
    Event Type
    Injury
    Date Received
    March 22, 2013
    Date of Event
    January 30, 2013
    Report Date
    March 22, 2013
    Product Code
    FMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RECEIVED TO DATE, IF PRODUCT IS RETURNED, ANALYSIS WILL BE CONDUCTED.

    Description of Event or Problem · 1

    THE PT EXPERIENCED AN INJECTION SITE REACTION WITH BD NEEDLES. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121086 PEN NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other