BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICAL STAINLESS STEEL SUTURE

    MDR report key: 915319 · Received September 19, 2007

    Report

    Report Number
    2210968-2007-00864
    Event Type
    Injury
    Date Received
    September 19, 2007
    Date of Event
    July 20, 2007
    Report Date
    August 20, 2007
    Manufacturer
    ETHICON, INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE ASSOCIATED WITH THIS EVENT IS NOT KNOWN. INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE PRODUCTS: LOT: TLP477, MFT DATE: 10/01/2004, EXP DATE: 7/31/2009. LOT: UCE167, MFG DATE: 3/1/2005, EXP DATE: 1/31/2010. CONCLUSION: A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED. THIS REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    INTERNATIONAL CUSTOMER REPORTS THAT A PATIENT DEVELOPED PAIN APPROXIMATELY TWO YEARS FOLLOWING AN ATRIAL-SEPTAL DEFECT REPAIR. AN X-RAY SHOWED THAT ONE OF THE THREE WIRES WAS BROKEN ON THE BACK SIDE OF THE STERNUM. NO TREATMENT WAS GIVEN. ONE MONTH LATER, THE PATIENT RETURNED COMPLAINING OF PAIN AND IT WAS FOUND THAT THE BROKEN WIRE HAD MOVED FROM ITS NOTED LOCATION IN 2007. TWO DAYS LATER, THE PATIENT PRESENTED WITH CARDIAC TAMPONADE THE PATIENT WAS RETURNED TO SURGERY AT WHICH TIME THE SURGEON CONFIRMED THAT THE SUTURE WAS BROKEN AND A PIECE HAD FALLEN INTO THE PERICARDIUM. THE FRAGMENT WAS RETRIEVED AND THE PATIENT IS REPORTED IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL STAINLESS STEEL SUTURE SUTURE, NON-ABSORBABLE GAT ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention