BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE

    MDR report key: 3054989 · Received March 19, 2013

    Report

    Report Number
    1836161-2013-00109
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 18, 2013
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    FZZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE MARKER WAS USED ON A CHILD APPROX (B)(6). IT WAS USED ON AN EYELID PRIOR TO AN EYE MUSCLE SURGERY. IT WAS REPORTED TO ME THAT THEY DID FLUSH THE EYE, BUT THE INK STILL DYED IT. THEY WERE ABLE TO COMPLETE THE SURGERY WITH NO SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113385 MEDLINE MARKING PEN FZZ ASPEN SURGICAL PRODUCTS, INC. 18482-*-*-1

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR