BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUTTON REPLACEMENT GASTROSTOMY DEVICE

    MDR report key: 1160026 · Received September 12, 2008

    Report

    Report Number
    3005099803-2008-04502
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Date of Event
    August 13, 2008
    Report Date
    August 14, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNT
    PMA / PMN Number
    K971906
    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 EVALUATION, 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 BUTTON REPLACEMENT GASTROSTOMY DEVICE WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED EIGHT DAYS LATER. ACCORDING TO THE COMPLAINANT, THE CAP FAILED TO CLOSE DUE TO A LEAK ONE WEEK AFTER PLACEMENT; THE PRODUCT REMAINS PLACED IN THE PATIENT'S BODY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'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 BUTTON REPLACEMENT GASTROSTOMY DEVICE KNT BOSTON SCIENTIFIC CORPORATION M00568190 11000654

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK