BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME RX SPHINCTEROTOME

    MDR report key: 1070411 · Received July 3, 2008

    Report

    Report Number
    3005099803-2008-01058
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    May 27, 2008
    Report Date
    June 4, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT WHEN THE HYDRATOME RX SPHINCTEROTOME DEVICE WAS REMOVED FROM ITS PACKAGE, "THE EXTREMITY OF THE DEVICE WAS BENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRATOME RX SPHINCTEROTOME KNS BOSTON SCIENTIFIC CORPORATION M00583010 11594635

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK