BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE STEP BUTTON INITIAL PLACEMENT GASTROSTOMY

    MDR report key: 1172909 · Received September 19, 2008

    Report

    Report Number
    3005099803-2008-04721
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 21, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KGC
    PMA / PMN Number
    K910584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE COMPLAINANT HAS INDICATED THAT THE SUSPECT DEVICE IS BEING RETURNED FOR EVAL; IT HAS NOT BEEN RECEIVED. THE DEVICE EVALUATION HAS NOT BEEN PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008, THAT A ONE STEP BUTTON INITIAL PLACEMENT GASTROSTOMY KIT WAS USED DURING AN UNK PROCEDURE PERFORMED ON TWO DAYS EARLIER. ACCORDING TO THE COMPLAINANT, UNABLE TO USE THE SCALP DUE TO A DULL EDGE. PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE (UNK PRODUCT). THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE STEP BUTTON INITIAL PLACEMENT GASTROSTOMY KGC BOSTON SCIENTIFIC CORPORATION M00568510 11800811

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK