BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE

    MDR report key: 1193493 · Received October 7, 2008

    Report

    Report Number
    3005099803-2008-05095
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 5, 2008
    Report Date
    September 9, 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 MFR DATE IS UNK. 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 CORP IN 2008, THAT A CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE WAS PLACED A WEEK PRIOR. ACCORDING TO THE COMPLAINANT, THE BUTTON LOCKING ADAPTER CRACKED 4 DAYS AFTER PLACEMENT. IT WAS REPORTED THAT THE DEVICE WAS REPLACED WITH ANOTHER CORFLO CUBBY LOW PROFILE 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 CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE KNT BOSTON SCIENTIFIC CORPORATION M00581240 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK