BEUDAMED
    FDA Adverse Event Other Summary report: N

    SURGIMEND

    MDR report key: 2434657 · Received January 27, 2012

    Report

    Report Number
    3004170064-2012-00002
    Event Type
    Other
    Date Received
    January 27, 2012
    Date of Event
    December 28, 2011
    Report Date
    January 27, 2012
    Manufacturer
    TEI BIOSCIENCES INC.
    Product Code
    FTM
    PMA / PMN Number
    K083898
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFG RECORD FOR THIS PRODUCT LOT WAS REVIEWED AND EVERYTHING WAS FOUND TO BE IN ORDER. TWO TYPES OF BACTERIA WERE PRESENT AT THE SURGICAL SITE. BOTH ARE KNOWN TO SECRETE COLLAGENASE. COLLAGENASE WILL ENZYMATICALLY DIGEST COLLAGEN-BASED BIOLOGIC DEVICES LIKE SURGIMEND IN A SHORT PERIOD OF TIME. THE LIKELY CAUSE OF THE FAILURE WAS THE PRESENCE OF BACTERIA THAT DIGESTED THE DEVICE.

    Description of Event or Problem · 1

    THE PT, AGE UNK, SEX, UNK, WEIGHT UNK, UNDERWENT SURGERY IN (B)(6) 2011, TO REPAIR AN ABDOMINAL DEFECT THAT MEASURED 34 CM X 24 CM. THE SURGIMEND DEVICE, 25 CM X 40 CM, LOT NUMBER 1108029 WITH AN EXPIRATION DATE OF 05/31/2016, WAS IMPLANTED TO COMPLETE THE REPAIR AND CLOSE THE DEFECT. A FEW DAYS LATER, IT WAS DETERMINED THAT THE DEVICE APPEARED TO BE THIN AND DISINTEGRATING IN AREAS. THE DEVICE WAS EXPLANTED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGIMEND SURGICAL MESH FTM TEI BIOSCIENCES INC. 606-300-016 1108029

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention