BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH

    MDR report key: 3040366 · Received March 12, 2013

    Report

    Report Number
    1836161-2013-00106
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    February 25, 2013
    Report Date
    March 12, 2013
    Manufacturer
    ASPEN SURGICAL PRODUCTS
    Product Code
    FZZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    SKIN MARKER IS SMEARING. ONE MARKER WAS USED ON THE SKIN (BREAST) AND THE SECOND WAS USED ON A PIECE OF MESH THAT WOULD BE PLACED IN THE ABDOMEN AND SMEARED OFF ONTO THE COLON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104296 CARDINAL HEALTH SKIN MARKER FZZ ASPEN SURGICAL PRODUCTS

    Patients

    Seq Age Sex Outcome Treatment
    1