BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDICAL ACTION SKIN MARKER

    MDR report key: 2987873 · Received February 21, 2013

    Report

    Report Number
    1836161-2013-00040
    Event Type
    Other
    Date Received
    February 21, 2013
    Date of Event
    January 26, 2011
    Report Date
    February 21, 2013
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    FZZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL, METHOD: MARKING PEN EVALUATED TO ENSURE WRITING. RESULTS: NO DEFECTS/FAILURES DETECTED. CONCLUSIONS: USER ERROR, MARKING PEN NOT BEING USED AS INTENDED.

    Additional Manufacturer Narrative · 1

    EVAL, METHOD: MARKING PEN EVALUATED TO ENSURE WRITING. RESULTS: NO DEFECTS/FAILURES DETECTED. CONCLUSIONS: USER ERROR, MARKING PEN NOT BEING USED AS INTENDED.

    Description of Event or Problem · 1

    INK SMEARING CAUSING A WRONG CUT ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75340 MEDICAL ACTION SKIN MARKER SKIN MARKER FZZ ASPEN SURGICAL PRODUCTS, INC. 094874, 105160

    Patients

    Seq Age Sex Outcome Treatment
    1 Other