BEUDAMED
    FDA Adverse Event Other Summary report: N

    SECURLINE STERILE SKIN MARKER

    MDR report key: 2987914 · Received February 21, 2013

    Report

    Report Number
    1836161-2013-00028
    Event Type
    Other
    Date Received
    February 21, 2013
    Date of Event
    June 18, 2010
    Report Date
    February 21, 2013
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    FZZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL - METHOD: DEVICE NOT EVALUATED. RESULTS: NO RESULTS ARE AVAILABLE AS NO EVAL WAS PERFORMED. CONCLUSIONS: INCONCLUSIVE INVESTIGATION.

    Description of Event or Problem · 1

    WHILE MARKING ON THE SKIN WITH A PEN, IT CUT THE PATIENT'S SKIN IN TWO PLACES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75115 SECURLINE STERILE SKIN MARKER SKIN MARKER FZZ ASPEN SURGICAL PRODUCTS, INC. 2015-03-29

    Patients

    Seq Age Sex Outcome Treatment
    1 Other