BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN SKIN MARKER/36

    MDR report key: 1634690 · Received March 17, 2010

    Report

    Report Number
    1226348-2010-00078
    Event Type
    Injury
    Date Received
    March 17, 2010
    Date of Event
    October 29, 2009
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    FZZ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE DEVICE IS NOT AVAILABLE FOR EVAL. WITHOUT THE DEVICE, IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. SINCE A LOT # HAS BEEN PROVIDED, A REVIEW OF THE MFG RECORDS HAVE BEEN REVIEWED AND THEY REVEALED THAT THE DEVICE CONFORMED TO ALL MFG AND QUALITY TESTING/INSPECTION SPECIFICATIONS PRIOR TO BEING RELEASED TO STOCK. THIS IS THE FIRST COMPLAINT FOR THIS LOT # AND THIS TYPE OF ISSUE. THEREFORE, IT IS CONSIDERED TO BE AN ISOLATED EVENT. IF AT SOME POINT THE DEVICE IS RETURNED FOR EVAL, THIS COMPLAINT WILL BE RE-OPENED AND INVESTIGATED. BASED ON THIS EVAL, NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME, THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    AFFILIATE REPORTS THAT: "SKIN MARKER WAS USED TO MARK SKIN AROUND THE EYE. AS SOON AS THE MARKER CAME INTO CONTACT WITH THE SKIN, INK LEAKED OUT OF THE MARKER AND FLEW INTO THE EYE (BLUE INK). THE EYE NEED TO BE FLUSHED AND THE ACTUAL SURGERY WAS POSTPONED. COMPLAINT SAMPLE IS NOT AVAILABLE FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODMAN SKIN MARKER/36 SKIN MARKER FZZ CODMAN & SHURTLEFF, INC. NA 09D0908

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention