BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE

    MDR report key: 1211344 · Received October 22, 2008

    Report

    Report Number
    3005099803-2008-05451
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    September 17, 2008
    Report Date
    September 24, 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

    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 CORPORATION IN 2008, THAT A CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE WAS PLACED TWENTY-THREE DAYS PRIOR. ACCORDING TO THE COMPLAINANT, SIXTEEN DAYS LATER, THE DEVICE BUTTON LOCKING ADAPTER WAS NOTED TO BE CRACKED. IT WAS ALSO REPORTED THAT THE ADAPTER WAS LOOSE-FITTING ON THE FEEDING TUBE LOCKING TAB. THE DEVICE WAS REPLACED WITH ANOTHER CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS 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 M00581250 0000029246

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK