BEUDAMED
    FDA Adverse Event Other Summary report: N

    SURGIMEND

    MDR report key: 1211505 · Received October 16, 2008

    Report

    Report Number
    3004170064-2008-00008
    Event Type
    Other
    Date Received
    October 16, 2008
    Date of Event
    September 12, 2008
    Report Date
    October 16, 2008
    Manufacturer
    TEI BIOSCIENCES INC.
    Product Code
    FTM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURING NARRATIVE: THE MANUFACTURING RECORD FOR THE PRODUCT LOT WAS REVIEWED AND EVERYTHING WAS IN ORDER. THIS PATIENT HAD A HISTORY OF MULTIPLE FAILED ABDOMINAL HERNIA REPAIRS. WHEN THE PRODUCT WAS IMPLANTED THERE HAD BEEN EVIDENCE OF CONTAMINATION WITHIN THE ABDOMINAL CAVITY. WHEN THE PATIENT WAS OPERATED ON A SECOND TIME, THERE WAS ALSO EVIDENCE OF BILE AND OTHER INTESTINAL FLUIDS IN THE ABDOMINAL CAVITY. THE POSSIBLE CONTAMINATION AND THE PRESENCE OF BILE AND OTHER INTESTINAL FLUIDS COULD HAVE RESULTED IN THE DETERIORATION OF THE PRODUCT.

    Description of Event or Problem · 1

    A FEMALE PATIENT, (B) (6), WEIGHT UNK, HEIGHT UNK, HAD A PRIOR HISTORY OF RECURRENT ABDOMINAL VENTRAL HERNIAS OVER SEVERAL YEARS. AT THE TIME OF THE SURGERY THE ABDOMINAL CAVITY WAS INFECTED WITH SOME QUANTITY OF BILE FLUIDS PRESENT. THIS SURGERY OCCURRED ON (B) (6) 2008. THE SURGIMEND DEVICE WAS IMPLANTED TO BRIDGE THE ABDOMINAL WALL DEFECT. THE DEVICE WAS SECURED WITH SUTURES BUT THE ENTIRE WOUND COULD NOT BE CLOSED RESULTING IN AN APPROXIMATELY 8 CM DIAMETER DEFECT WAS COVERED WITH VASELINE AND A DRESSING. ON (B) (6) 2008 OR (B) (6) 2008, THE SURGEON OBSERVED THAT THE PRODUCT HAD DETERIORATED SOMEWHAT ALONG THE MIDLINE. AT THAT TIME RE-OPERATION WAS PERFORMED. THE SURGEON CLOSED THE SURGIMEND PRODUCT WITH SUTURES. IT WAS NOTED THAT THE ABDOMINAL CAVITY WAS FILLED WITH BILE AND OTHER INTESTINAL FLUIDS. AT THIS TIME, THE PATIENT IS DOING FINE. ONE PRODUCT DEVICE WAS USED DURING THE INITIAL SURGERY. THE PART NUMBER OF THE DEVICE WAS 606-001-009. THE PRODUCT LOT NUMBER WAS 0801019 WITH AN EXPIRATION DATE OF AUGUST 2010. THE ORIGINAL DEVICE WAS NOT EXPLANTED. NO EVALUATION OF THE DEVICE WAS POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGIMEND SURGICAL MESH FTM TEI BIOSCIENCES INC. 0801019

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention