BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE

    MDR report key: 1810005 · Received August 12, 2010

    Report

    Report Number
    2210968-2010-00909
    Event Type
    Injury
    Date Received
    August 12, 2010
    Date of Event
    July 9, 2010
    Report Date
    July 12, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    GAW
    PMA / PMN Number
    N16374
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: REP SAMPLES WERE RETURNED FOR EVAL. THEY WERE VISUALLY AND FUNCTIONALLY EXAMINED FOR SUTURE KNOT TENSILE STRENGTH AND THEY MET THE REQUIREMENTS. CONCLUSION: THE DEVICES WERE 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 AN INFANT UNDERWENT A CORONARY ARTERY BYPASS GRAFT WITH INTERNAL MAMMARY ARTERY PROCEDURE ON (B)(6) 2010, AND SUTURE WAS USED. AFTER THE PROCEDURE WAS COMPLETE, THE SUTURE BROKE. THE SURGEON NEEDED TO REOPEN AND RESUTURE THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLENE POLYPROPYLENE SUTURE SUTURE, NON-ABSORBABLE GAW ETHICON, INC. NA BKR393

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention