BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXCEL POLYESTER SUTURE

    MDR report key: 4113678 · Received September 24, 2014

    Report

    Report Number
    2210968-2014-13659
    Event Type
    Injury
    Date Received
    September 24, 2014
    Date of Event
    August 19, 2014
    Report Date
    September 3, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR EVALUATION, ANY FURTHER INFO DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    CONCLUSION: REPRESENTATIVE SAMPLES WERE RETURNED FOR EVALUATION. THEY WERE VISUALLY AND FUNCTIONALLY EXAMINED FOR TENSILE STRENGTH AND THEY MET THE REQUIREMENTS. NO DEVICE FAILURE DETECTED AND THE PRODUCTS ARE WITHIN SPECIFICATION.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A STOMAL HERNIA REPAIR PROCEDURE ON (B)(6) 2014 AND SUTURE WAS USED IN THE ABDOMINAL FASCIA. ON (B)(6) 2014, THE SURGEON HAD TO BRING THE PATIENT BACK FOR SURGERY TO CLOSE THE HERNIA DEFECT THAT HAD OPENED UP. ALL OF THE STITCHES THAT HE HAD THROWN HAD OPENED UP BECAUSE THE KNOTS HAD COME UNTIED. THE ORIGINAL SUTURES WERE PLACED IN AN INTERRUPTED SUTURING TECHNIQUE AND TIED BY HAND WITH HALF-HITCH COMBINATION SQUARE KNOTS. THE PATIENT UNDERWENT AN OPEN REOPERATION AND A DIFFERENT SUTURE WAS USED. THE PATIENT HAS RECOVERED WELL POST-OPERATIVELY AFTER THE SECOND SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN VENTRAL HERNIA REPAIR PROCEDURE ON (B)(6) 2014 AND SUTURE WAS USED. ON (B)(6) 2014, THE SURGEON HAD TO BRING THE PATIENT BACK FOR SURGERY TO CLOSE THE HERNIA DEFECT THAT HAD OPENED UP. ALL OF THE STITCHES THAT HE HAD THROWN HAD OPENED UP BECAUSE THE KNOTS HAD COME UNTIED. THE PATIENT UNDERWENT AN OPEN REOPERATION AND A DIFFERENT SUTURE WAS USED. PATIENT HAS RECOVERED WELL POST-OPERATIVELY AFTER THE SECOND SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595323 ETHIBOND EXCEL POLYESTER SUTURE SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC. UNK GKB298

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention