BEUDAMED
    FDA Adverse Event Other Summary report: N

    STAT SUPER-FINE PEN NEEDLES

    MDR report key: 1587835 · Received January 25, 2010

    Report

    Report Number
    1058955-2010-00001
    Event Type
    Other
    Date Received
    January 25, 2010
    Report Date
    January 22, 2010
    Manufacturer
    STAT MEDICAL DEVICES, INC.
    Product Code
    FMI
    PMA / PMN Number
    K092016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FOR THIS INCIDENT NO CONCLUSION MAY BE DETERMINED AS THE DEFECTIVE PRODUCT WAS NOT RETURNED.

    Description of Event or Problem · 1

    PATIENT REPORTED THAT A PEN NEEDLES GOT STUCK IN HIS ABDOMINAL WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAT SUPER-FINE PEN NEEDLES INSULIN PEN NEEDLES FMI STAT MEDICAL DEVICES, INC. UNAVAILABLE UNAVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other