BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE

    MDR report key: 2971947 · Received January 21, 2013

    Report

    Report Number
    1836161-2013-00004
    Event Type
    Malfunction
    Date Received
    January 21, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 21, 2013
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    FZZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WAITING FOR SAMPLE TO BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE SKIN MARKER EXPLODED IN THE PT'S EYE. THE EYE WAS FLUSHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28880 MEDLINE SKIN MARKER FZZ ASPEN SURGICAL PRODUCTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention