BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER FINE PEN NEEDLE

    MDR report key: 1378323 · Received April 27, 2009

    Report

    Report Number
    1058955-2009-00004
    Event Type
    Other
    Date Received
    April 27, 2009
    Report Date
    April 24, 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
    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

    TECH FROM PHARMACY IS REPORTING PTS HAVE COMPLAINED THAT THE PEN NEEDLES ARE BREAKING. NO ADDITIONAL INFO IS AVAILABLE AND PRODUCT WILL NOT BE RETURNED TO THE MFR FOR INVESTIGATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK