BEUDAMED
    FDA Adverse Event Death Summary report: N

    STRATAFIX KNOTLESS TISSUE CONTROL DEVICE

    MDR report key: 3667571 · Received February 11, 2014

    Report

    Report Number
    3008845715-2014-00002
    Event Type
    Death
    Date Received
    February 11, 2014
    Date of Event
    January 2, 2014
    Report Date
    February 7, 2014
    Manufacturer
    SURGICAL SPECIALTIES PUERTO RICO INC.
    Product Code
    NEW
    PMA / PMN Number
    K051609
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PER CUSTOMER COMMUNICATION ONE DEVICE WILL BE RETURNED. THE DEVICE IS NOT AVAILABLE AT THIS MOMENT. METHOD: ONE DEVICE WILL BE RETURNED. THE DEVICE HAVE IS NOT AVAILABLE AT THIS MOMENT. RESULTS/CONCLUSIONS: THE DEVICE HAVE IS NOT AVAILABLE AT THIS MOMENT. REFER TO ATTACHED NARRATIVE FOR ADDITIONAL RESULTS. NO INVENTORY AVAILABLE FOR THE FINISHED GOOD LOT REPORTED. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "FOLLOWING AN UNK PROCEDURE THE PT WAS OPERATED INTERNALLY WITH A FIXATOR. THE WOUND WAS CLOSED IN TWO LAYERS. MUSCLES WITH A LER VICRYL AND THE FASCIA WITH STRATAFIX. THE PT RECEIVED A WOUND INFECTION AND HAD AT TO 2:01 BE REVISED. A SHORT TIME LATER THE PT DIED. THE SURGEON TOLD ME THAT THE BRITTLE VORFAND THE STRATAFIX THREAD IN THE FABRIC AND NOW WAS SKEPTICAL ABOUT THE STRATAFIX AND THIS TIME BEING NO LONGER USED. WHETHER THERE IS A DIRECT CONNECTION AND WHETHER NO LONGER USE. WHETHER THERE IS A DIRECT CONNECTION AND WHETHER STRATAFIX TRIGGERING FACTOR FOR WOUND INFECTION, HE COULD NOT CONFIRM WITH ME". (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91264 STRATAFIX KNOTLESS TISSUE CONTROL DEVICE BARBED MATERIAL/ NEEDLES NEW SURGICAL SPECIALTIES PUERTO RICO INC. SXPD2B405 MBMZ790

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Death NONE MADE AVAILABLE.