BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL SUTURE

    MDR report key: 2063290 · Received April 19, 2011

    Report

    Report Number
    2210968-2011-00466
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 12, 2011
    Report Date
    March 24, 2011
    Manufacturer
    ETHICON INC
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WOUND DEHISCENCE. RESULT: REPRESENTATIVE SAMPLES OF THE PRODUCT WERE RETURNED FOR EVALUATION. THE SAMPLES WERE INSPECTED AND TESTED FOR KNOT PULL TENSILE STRENGTH . THERE WERE NO SIGNS OF MANUFACTURING OR MATERIAL DEFECTS FOUND. CONCLUSION: NO DEVICE FAILURE DETECTED AND THE PRODUCT IS WITHIN SPECIFICATION.

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: ONE INTACT FOIL WAS RETURNED FOR EVALUATION. THIS COMPLAINT SAMPLE AND FIVE RETAIN SAMPLES WERE TAKEN FOR ANALYSIS. THESE SAMPLES WERE OPENED AND INSPECTED VISUALLY. NO DAMAGE OR SUTURE RELATED DEFECTS WERE OBSERVED IN THESE SAMPLES. THE COMPLAINT AND RETAIN SAMPLES WERE TESTED FOR KNOT PULL TENSILE STRENGTH TEST AND FOUND TO MEET IN-HOUSE REQUIREMENTS. THE RETAINED SAMPLES WERE TESTED FOR IN-VITRO TEST AND FOUND TO MEET THE IN-HOUSE REQUIREMENTS INDICATING A NORMAL ABSORPTION PATTERN OF THE SUTURES. CONCLUSION: THE DEVICE WAS RECEIVED IN A CONDITION THAT MEETS SPECIFICATION. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION PROCEDURE ON (B)(6) 2011 AND SUTURE WAS USED. THE INCISION WAS HYPOGASTRIC MEDIAN-PERPENDICULAR. THREE TO FOUR DAYS AFTER THE PROCEDURE, THE FAT UNDER THE SKIN WAS "LIQUEFACTION". WHEN THE SURGEON CHANGED THE PATIENT'S MEDICINE, THE FRONT VAGINAL INCISION LINE WAS OPEN. THE SUTURE FLOATED ON THE TISSUE AND THERE WAS WATER SEEPAGE BETWEEN THE FAT AND THE VAGINA. THE SURGEON CUT THE SUTURE, USED IODINE AND SUTURED THE WOUND WITH THE MERSILK AFTER THREE DAYS. CURRENTLY, THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COATED VICRYL SUTURE SUTURE, ABSORBABLE GAM ETHICON INC NA T0032

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention