BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM PATHWAY INTRODUCER

    MDR report key: 805993 · Received January 3, 2007

    Report

    Report Number
    2025576-2007-00001
    Event Type
    Malfunction
    Date Received
    January 3, 2007
    Date of Event
    December 4, 2006
    Report Date
    December 5, 2006
    Manufacturer
    BYRON MEDICAL
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WAS NOT RETURNED FOR EVALUATION. DEVICES FROM THE SAME LOT WERE REVIEWED. NONE OF THESE DEVICES APPEARED TO HAVE ANY DEFECTS THAT WOULD RESULT IN THE REPORTED EVENT. NO CONCLUSIONS COULD BE DRAWN. IF THE DEVICE IS RETURNED, ADDITIONAL INVESTIGATION WILL BE DONE.

    Description of Event or Problem · 1

    THE BUTTON TIP OF THE PATHWAY INTRODUCER CAME OFF DURING SURGERY. IT WAS NOT DISCOVERED UNTIL THE DOCTOR WAS PERFORMING THE ABDOMINAL PLASTY AND THE PIECE WAS DISCOVERED IN THE REMOVED TISSUE. (THE ABDOMINAL PLASTY WAS A SCHEDULED PROCEDURE, AND ADDITIONAL PROCEDURES WERE NOT REQUIRED.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5MM PATHWAY INTRODUCER PATHWAY INTRODUCER DYB BYRON MEDICAL PWI-1700B PW5938

    Patients

    Seq Age Sex Outcome Treatment
    1 *