BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE STEP BUTTON INITIAL PLACEMENT GASTROSTOMY

    MDR report key: 1070391 · Received July 3, 2008

    Report

    Report Number
    3005099803-2008-01070
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    June 3, 2008
    Report Date
    June 4, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KGC
    PMA / PMN Number
    K910584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DATE OF MFR CANNOT BE DETERMINED. ALTHOUGH THE COMPLAINANT INDICATED THAT THE SUSPECT DEVICE WOULD BE RETURNED, IT HAS NOT BEEN RECEIVED. THEREFORE, A DEVICE EVALUATION HAS NOT BEEN COMPLETED AND THE CAUSE OF THE REPORTED MALFUNCTION IS CURRENTLY UNDETERMINED.

    Description of Event or Problem · 1

    IN 2008, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ONE STEP BUTTON ENTERAL FEEDING DEVICE WAS PLANNED TO BE USED ON THE PREVIOUS DAY; HOWEVER, ACCORDING TO THE COMPLAINANT, WHEN THE PACKAGE WAS OPENED, THE KIT WAS MISSING COMPONENTS. IT WAS REPORTED THAT THE PHYSICIAN COMPLETED THE PROCEDURE ON THE FOLLOWING DAY. NO FURTHER INFORMATION HAS BEEN ASCERTAINABLE FROM THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE STEP BUTTON INITIAL PLACEMENT GASTROSTOMY KGC BOSTON SCIENTIFIC CORPORATION M00563190 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK