BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE

    MDR report key: 1203238 · Received October 17, 2008

    Report

    Report Number
    3005099803-2008-05341
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Report Date
    September 19, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNT
    PMA / PMN Number
    K990127
    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 MANUFACTURE DATE IS UNK. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED OF AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    NOTE: DATE OF EVENT IS UNK. IT WAS REPORTED TO BOSTON SCIENTIFIC CORP ON SEPT 19, 2008, THAT A CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE WAS USED IN A FEEDING PROCEDURE. ACCORDING TO THE COMPLAINANT, APPROXIMATELY 1 MONTH AFTER PLACEMENT, THE LOCKING TAB WAS BROKEN. ANOTHER CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE WAS USED TO REPLACE THE BROKEN LOCKING TAB. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PT'S CONDITION WAS REPORTED TO BE "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE KNT BOSTON SCIENTIFIC CORPORATION M00581510 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK