BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE

    MDR report key: 1171407 · Received September 17, 2008

    Report

    Report Number
    3005099803-2008-04657
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 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 ABLE 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008 THAT A CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE WAS USED DURING A FEEDING PROCEDURE PERFORMED THE DAY BEFORE. ACCORDING TO THE COMPLAINANT, THE BALLOON RUPTURED TWO DAYS AFTER PLACEMENT OUTSIDE THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE 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 CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE KNT BOSTON SCIENTIFIC CORPORATION M00581090 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK