BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-FIX AB CURVED NEEDLE DELIVERY SYS.

    MDR report key: 1014076 · Received March 14, 2008

    Report

    Report Number
    1219602-2008-00061
    Event Type
    Malfunction
    Date Received
    March 14, 2008
    Date of Event
    January 8, 2008
    Report Date
    January 8, 2008
    Manufacturer
    SMITH & NEPHEW INC., ENDOSCOPY DIV.
    Product Code
    GAS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT WAS INITIALLY ASSESSED AS NOT REPORTABLE ON 2/4/2008; HOWEVER, ADDITIONAL INFO BECAME AVAILABLE TO S&N ON APPROX TWO WEEKS LATER, INDICATING THAT THE DEVICE REMAINS IN THE PT.

    Description of Event or Problem · 1

    IN 2008, SALES REP CONFIRMED THAT THE SURGEON WAS ABLE TO SECURE THE T'S WITH TWO OF THESE DEVICES. IT WAS NECESSARY TO CUT THE SUTURES AWAY AND LEAVE THE T'S IN THE PT ON ONE DEVICE. AN ADDITIONAL DEVICE WAS OPENED AS A RESULT. THERE WERE NO PT INJURY OR COMPLICATIONS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FAST-FIX AB CURVED NEEDLE DELIVERY SYS. FAST-FIX AB GAS SMITH & NEPHEW INC., ENDOSCOPY DIV. 7209399 50234782

    Patients

    Seq Age Sex Outcome Treatment
    1