BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-FIX AB CURVED NEEDLE DELIVERY SYSTEM

    MDR report key: 1070524 · Received July 1, 2008

    Report

    Report Number
    1219602-2008-00154
    Event Type
    Malfunction
    Date Received
    July 1, 2008
    Date of Event
    June 4, 2008
    Report Date
    June 5, 2008
    Manufacturer
    SMITH & NEPHEW INC., ENDOSCOPY DIV.
    Product Code
    GAS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NOT BEING RETURNED FOR EVAL.

    Description of Event or Problem · 1

    DURING USE IN SURGERY, THE SUTURE KNOTS FAILED. T1 WAS LEFT UNSUPPORTED IN THE PT. NO PT INJURY REPORTED AND BACK-UP DEVICES WERE AVAILABLE TO COMPLETE THE PROCEDURE. THERE IS NO ADDITIONAL INFO AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FAST-FIX AB CURVED NEEDLE DELIVERY SYSTEM FAST-FIX AB GAS SMITH & NEPHEW INC., ENDOSCOPY DIV. 7209399 50249215

    Patients

    Seq Age Sex Outcome Treatment
    1