BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO CUBBY DUAL PORT STANDARD BALLOON

    MDR report key: 1222915 · Received November 6, 2008

    Report

    Report Number
    3005099803-2008-06133
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Report Date
    October 10, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNT
    PMA / PMN Number
    K990127
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    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 EVAL HAS NOT BEEN 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 IN 2008, THAT A CORFLO CUBBY DUAL PORT STANDARD BALLOON WAS USED IN A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PROCEDURE. ACCORDING THE COMPLAINANT, "THE DEVICE SPONTANEOUSLY CAME OFF FROM THE BODY." THIS DEVICE WAS REPLACED WITH ANOTHER DEVICE (DEVICE UNK). 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 CORFLO CUBBY DUAL PORT STANDARD BALLOON KNT BOSTON SCIENTIFIC CORPORATION M00581420 0000027689

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK