BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C.R.E. BALLOON DILATATION CATHETER

    MDR report key: 1140702 · Received August 28, 2008

    Report

    Report Number
    3005099803-2008-04152
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    July 25, 2008
    Report Date
    July 30, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORK LTD.
    Product Code
    KNQ
    PMA / PMN Number
    K971320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PACKAGE WAS OPENED THERE WAS NO PRODUCT INSIDE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C.R.E. BALLOON DILATATION CATHETER KNQ - BALLOON DILATATION CATHETER KNQ BOSTON SCIENTIFIC CORK LTD. M00558380 0011573384

    Patients

    Seq Age Sex Outcome Treatment
    1