BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURLINE STERILE SKIN MARKER WITH RULER

    MDR report key: 3760995 · Received April 11, 2014

    Report

    Report Number
    1836161-2014-00027
    Event Type
    Injury
    Date Received
    April 11, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 11, 2014
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    FZZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER CALLED AND REPORTED THEY USED THIS SKIN MARKER ON A PT'S EYE, AND THE MARKER EXPLODED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220658 SECURLINE STERILE SKIN MARKER WITH RULER STERILE SKIN MARKER WITH RULER FZZ ASPEN SURGICAL PRODUCTS, INC. 1000-00-PDG 40174

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention