BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGILENE T-20

    MDR report key: 39718 · Received September 27, 1996

    Report

    Report Number
    2648188-1996-00008
    Event Type
    Injury
    Date Received
    September 27, 1996
    Date of Event
    August 1, 1996
    Report Date
    September 5, 1996
    Manufacturer
    SHERWOOD DAVIS AND GECK
    Product Code
    GAW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE MFR COMPLAINT #Z96-317. CUSTOMER RETURNED SUTURES WERE EVALUATED. THE MANUFACTURING PLANT REVIEWED THE DEVICE HISTORY RECORDS. RECORDS FOUND THE LOT MET ALL INTERNAL OPERATING STANDARDS AND PROCEDURES AND ALL APPLICABLE USP SPECS. KNOT PULL STRENGTH TESTING WAS PERFORMED ON THE RETURNED SAMPLES. ALL RESULTS MET OR EXCEEDED ORIGINAL KPS TEST RESULTS AND WERE WELL ABOVE THE USP AVERAGE OF 6 LBS MINIMUM. NO OTHER REPORTS HAVE BEEN RECEIVED AGAINST THIS LOT SINCE ITS RELEASE (4/96). CO IS UNABLE TO DETERMINE A PROBABLE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    A PT WITH A HISTORY OF ABDOMINAL AORTIC ANEURYSM UNDERWENT REPAIR OF AORTIC RUPTURE. THE SUTURE WAS USED IN CONTINUOUS FASHION FOR FASCIAL CLOSURE. APPROX ONE WEEK POSTOPERATIVELY, THE PT EXPERIENCED ABDOMINAL WOUND DEHISCENCE WITH INFECTION, AND A REOPERATION WAS NECESSITATED. DURING RE-EXPLORATION, SUTURE WAS NOTED TO BE BROKEN. FOLLOWING THE RE-OPERATION, THE PT HAS BEEN DOING WELL. THE DOCTOR SUSPECTS THE INFECTION WAS A RESULT OF WOUND DEHISCENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGILENE T-20 Implant SUTURE GAW SHERWOOD DAVIS AND GECK NA 947391

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention