BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGISIS HERNIA GRAFT

    MDR report key: 1623699 · Received March 4, 2010

    Report

    Report Number
    1835959-2010-00003
    Event Type
    Injury
    Date Received
    March 4, 2010
    Date of Event
    February 5, 2010
    Report Date
    March 4, 2010
    Manufacturer
    COOK BIOTECH, INC.
    Product Code
    FTL
    PMA / PMN Number
    K031850
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COOK BIOTECH UNDERSTANDS THAT CHOLESTEATOMA IS A SERIOUS CONDITION OF THE MIDDLE EAR. CHOLESTEATOMA MUST HE ENTIRELY REMOVED, OCCASIONALLY REQUIRING RADICAL EXCISIONS OF MIDDLE EAR AND MASTOID. REMAINING CHOLESTEATOMA WILL PROPAGATE AND CONTINUE TO SPREAD AND INVADE. IT IS POSTULATED THAT REMAINING CHOLESTEATOMA MAY HAVE LED TO THIS OUTCOME.

    Description of Event or Problem · 1

    ON (B)(6) 2010 (B)(6) VP OF RESEARCH AND CLINICAL AFFAIRS FOR COOK BIOTECH INC., CONTACTED DR. (B)(6) AND PROVIDED THIS REPORT. PT IS A LADY THAT HAS A HISTORY OF A TUMOR WITH A CHOLESTEATOMA OF THE RIGHT EAR THAT WAS "EATING" INTO THE JAW JOINTS. SHE ALSO HAS A HISTORY OF ANOTHER LARGE TUMOR AND IS GETTING CHEMO WITH GLEEVEC ON A LONG TERM BASIS. THE TUMOR INVADED HER STOMACH AND SPLEEN, AND HAD PARTIAL REMOVAL OF BOTH. DR. (B)(6) DID SURGERY ON (B)(6) 2009 ON HER WITH SOME TITANIUM MESH ON THE TMJ CAPSULE SIDE, THEN PUT SOME SURGISIS BETWEEN THAT AND THE EAR CANAL. HE THEN PUT SOME CARTRIDGE ON THE EAR SIDE. THE EARDRUM WAS FLESHY AND TORN UP AS A CONSEQUENCE OF THE CHOLESTEATOMA, AND DR. (B)(6) PUT SOME SURGISIS RIGHT UNDER THE EARDRUM AND UNDER THE EAR CANAL SKIN. THE EAR DRUM IS NOW (HE SAW HER RECENTLY) ROUGHLY 10X AS THICK AS IT SHOULD BE. SHE CAN'T HEAR IN THAT EAR. HE'S BEEN TREATING HER WITH DROPS THAT HAVE ABX AND A STEROID IN THEM. HE WILL GO BACK IN AND REMOVE THE WHOLE THING TO SEND FOR PATHOLOGY. WHEN HE OPERATED ON HER HE DID NOT KNOW ABOUT REACTION OF IMMUNO SUPPRESSED PTS. DR. (B)(6) SUCCESS IS "100% IN ALL THE OTHERS". HE ESTIMATES HE HAS DONE 100 PTS WITH SURGISIS FOR TYMPANOPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGISIS HERNIA GRAFT SURGICAL MESH FTL COOK BIOTECH, INC. G31320 LB431376

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention