BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL SUTURE

    MDR report key: 2063286 · Received April 19, 2011

    Report

    Report Number
    2210968-2011-00464
    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. CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Additional Manufacturer Narrative · 1

    (B)(4). IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). RESULT: REPRESENTATIVE SAMPLES OF THE PRODUCT WERE RETURNED FOR EVALUATION. THE SAMPLES WERE OPENED AND INSPECTED VISUALLY. NO DAMAGE OR DEFECTS WERE OBSERVED IN THESE SAMPLES. THE SAMPLES WAS TESTED FOR KNOT PULL TENSILE STRENGTH TEST AND FOUND TO MEET IN-HOUSE REQUIREMENTS. NO DEVICE FAILURE DETECTED AND THE PRODUCT IS WITHIN SPECIFICATION.

    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