BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE

    MDR report key: 4251040 · Received November 14, 2014

    Report

    Report Number
    2210968-2014-15788
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 3, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. THE SAMPLES WERE VISUALLY AND FUNCTIONALLY TESTED FOR STRENGTH AND THE SAMPLES MET THE REQUIREMENTS

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT ANASTOMOSIS BETWEEN SAPHENOUS VEIN AND AORTA ON (B)(6) 2014 AND SUTURE WAS USED. AS THE PROCEDURE WAS BEING COMPLETED, THE ANASTOMOSIS BROKE AND THE PROCEDURE WAS RE-STARTED. THE PATIENT EXPERIENCED BLOOD LOSS AND TRANSFUSION WAS REQUIRED. THE PROCEDURE WAS COMPLETED WITH A LIKE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736387 PROLENE POLYPROPYLENE SUTURE SUTURE, NONABSORBABLE, SYNTHETIC GAW ETHICON INC. HGR600

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention