BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDINAL

    MDR report key: 2987379 · Received February 21, 2013

    Report

    Report Number
    1836161-2013-00084
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    October 3, 2012
    Report Date
    February 22, 2013
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    FZZ
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO TESTING METHODS WERE PERFORMED AS THE DEVICE WAS NOT RETURNED FOR EVAL. NO RESULTS AVAILABLE AS THE DEVICE WAS NOT RETURNED FOR EVAL. DEVICE WAS NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    THE TIP IN THE SURGICAL MARKING PEN IS TOO POINTED AND SHARP. WHEN SURGEON WENT TO MARK THE SKIN, IT CUT THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75360 CARDINAL SKIN MARKER FZZ ASPEN SURGICAL PRODUCTS, INC. 4277

    Patients

    Seq Age Sex Outcome Treatment
    1 Other