BEUDAMED
    FDA Adverse Event Other Summary report: N

    SECURLINE SKIN MARKER

    MDR report key: 2987875 · Received February 21, 2013

    Report

    Report Number
    1836161-2013-00015
    Event Type
    Other
    Date Received
    February 21, 2013
    Date of Event
    February 19, 2010
    Report Date
    February 21, 2013
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    FZZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: SKIN MARKER WAS RETURNED AND WRITE TESTED. RESULTS: NO FAILURE DETECTED. CONCLUSIONS: INCONCLUSIVE, NOT ROOT CAUSE DETERMINED AS DEVICE OPERATED WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    TIP OF PEN WAS TOO SHARP AND LEFT RED MARKS ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75209 SECURLINE SKIN MARKER SKIN MARKER FZZ ASPEN SURGICAL PRODUCTS, INC. 2014-12-10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other