BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT SUPER-FINE PEN NEEDLE

    MDR report key: 1472083 · Received June 9, 2009

    Report

    Report Number
    1058955-2009-00005
    Event Type
    Malfunction
    Date Received
    June 9, 2009
    Report Date
    May 28, 2009
    Manufacturer
    STAT MEDICAL DEVICES, INC.
    Product Code
    FMI
    PMA / PMN Number
    K042917
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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

    PHARMACIST REPORTED TWO (2) PATIENTS COULD NOT GET THEIR DOSE TO COME OUT WITH THE SUPER-FINE PEN NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAT SUPER-FINE PEN NEEDLE INSULIN PEN NEEDLE FMI STAT MEDICAL DEVICES, INC. PNX-100 11/01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other