BEUDAMED
    FDA Adverse Event Other Summary report: N

    SURGIMEND

    MDR report key: 1141350 · Received August 28, 2008

    Report

    Report Number
    3004170064-2008-00007
    Event Type
    Other
    Date Received
    August 28, 2008
    Date of Event
    August 3, 2008
    Report Date
    August 28, 2008
    Manufacturer
    TEI BIOSCIENCES INC.
    Product Code
    FTM
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECT MEDICAL DEVICE: ONE PRODUCT DEVICE WAS USED DURING THE INITIAL SURGERY. THE PART NUMBER OF THE DEVICE WAS 606-001-006. THE PRODUCT LOT NUMBERS WERE 0803029 WITH AN EXPIRATION DATE OF SEPT 2010. THE ORIGINAL DEVICE WAS NOT EXPLANTED. NO EVALUATION OF THE DEVICE WAS POSSIBLE. THE MFG RECORD FOR THE PRODUCT LOT WAS REVIEWED AND EVERYTHING WAS IN ORDER. COUGHING FOLLOWING THIS TYPE OF SURGERY INCREASE THE LIKELIHOOD OF HAVING THE PROCEDURE FAIL, BECAUSE OF THE STRESS PLACED ON BOTH THE DEVICE AND THE PT'S OWN TISSUE. IT IS POSSIBLE THAT THE SUTURE KNOTS USED TO SECURE THE PRODUCT WAS TIED TOO TIGHTLY RESULTING IN THE SUTURE PULLING THROUGH THE PRODUCT RIGHT AT THAT POINT. IT IS ALSO POSSIBLE THAT THE PT'S COUGHING PLACED TOO MUCH STRESS ON THE PRODUCT RESULTING IN THE PARTIAL FAILURE.

    Description of Event or Problem · 1

    A FEMALE PT, AGE UNK, WEIGHT (B) (6), HEIGHT (B) (6) HAD A PRIOR HISTORY OF ABDOMINAL VENTRAL HERNIA. SURGERY WAS SCHEDULED TO REPLACE A FAILED ENCAPSULATED SYNTHETIC MESH. THIS SURGERY OCCURRED ON (B) (6) 2008. THE SURGIMEND DEVICE WAS IMPLANTED AS AN UNDERLAY TO BRIDGE THE ABDOMINAL WALL DEFECT. THE DEVICE WAS SECURED WITH HORIZONTAL MATTRESS SUTURES WITH SUFFICIENT OVERLAP TO NORMAL TISSUE. A DRAIN WAS ALSO INSERTED. ON (B) (6) 2008, THE SURGEON NOTICED A SMALL BULGE IN THE PT'S ABDOMEN. THE PT INDICATED SHE HAD BEEN COUGHING A LOT. ON (B) (6) 2008, DURING RE-OPERATION, IT WAS NOTED THAT THE SURGIMEND DEVICE HAD TORN FROM THE SUTURES. THE SURGEON REATTACHED THIS DEVICE AND ALSO ADDED A SECOND SURGIMEND DEVICE. THIS DEVICE WAS ADDED AS AN OVERLAY. AT THIS TIME, THE PT IS DOING FINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention