BEUDAMED
    FDA Adverse Event Other Summary report: N

    CARDINAL CLASSIC MARKING PEN

    MDR report key: 2979988 · Received February 22, 2013

    Report

    Report Number
    1836161-2013-00054
    Event Type
    Other
    Date Received
    February 22, 2013
    Date of Event
    June 17, 2011
    Report Date
    February 22, 2013
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    FZZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO A RECENT FDA INSPECTION THIS MDR IS BEING REPORTED LATE AS A RESULT OF A RE-EVALUATION. NO EVALUATION PERFORMED AS THE DEVICE WAS NOT RETURNED. NO RESULTS AS NO EVALUATION WAS PERFORMED. INCONCLUSIVE BUT POTENTIALLY CAUSED BY THE PRESSURE THE PRESSURE THE USER WAS APPLYING WHEN DRAWING ON THE SKIN. THERE IS NO CONTROLS THAT CAN BE PUT INTO PLACE TO PREVENT THIS.

    Description of Event or Problem · 1

    DURING A CASE THE PT WAS CUT WITH THE TIP OF THE PEN. WHILE THE DOCTOR WAS OUTLINING THE INCISION AREA THE INK WAS NOT VERY DARK WHICH MADE HIM PRESS MORE FIRMLY, AS HE PRESSED DOWN A LINE OF BLOOD WAS VISUALIZED WHERE WE EXPECT TO FIND THE PEN MARKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78403 CARDINAL CLASSIC MARKING PEN SKIN MARKER FZZ ASPEN SURGICAL PRODUCTS, INC. 2010-10-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other