BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN SURGICAL MARKER/36

    MDR report key: 857871 · Received May 31, 2007

    Report

    Report Number
    1226348-2007-00156
    Event Type
    Injury
    Date Received
    May 31, 2007
    Product Code
    FZZ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE PRODUCT IS AVAILABLE FOR EVAL. UPON COMPLETION OF THE INVESTIGATION, A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT THE EYE INSTITUTE EXPLANTED THAT THEY SAW LAMELLAR KERATITIS APPEAR IN A SERIES OF PTS WHILE USING SKIN MARKERS, WHICH MAY HAVE CONTRIBUTED TO THIS CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODMAN SURGICAL MARKER/36 NONE FZZ NA 06H1496

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention