BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUTTON REPLACEMENT GASTROSTOMY DEVICE

    MDR report key: 1230741 · Received October 28, 2008

    Report

    Report Number
    3005099803-2008-05516
    Event Type
    Malfunction
    Date Received
    October 28, 2008
    Report Date
    September 29, 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

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE MFR DATE IS UNK. ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVAL HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    NOTE: THE DATE OF EVENT IS UNK. IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT TWO WEEKS AFTER PLACING A BUTTON REPLACEMENT GASTROSTOMY DEVICE (ADULT PATIENT BETWEEN 50 AND 60 YEARS OF AGE), THE CAP OF THE FLANGE WOULD NOT CLOSE. ACCORDING TO THE COMPLAINANT, THE DEVICE WAS REPLACED WITH ANOTHER BUTTON REPLACEMENT GASTROSTOMY DEVICE. 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 BUTTON REPLACEMENT GASTROSTOMY DEVICE KNT BOSTON SCIENTIFIC CORPORATION M00568340 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1