BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE

    MDR report key: 1230736 · Received October 28, 2008

    Report

    Report Number
    3005099803-2008-05539
    Event Type
    Malfunction
    Date Received
    October 28, 2008
    Report Date
    September 30, 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 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: THE DATE OF EVENT IS UNK. IT WAS REPORTED TO BOSTON SCIENTIFIC CORP. IN 2008, THAT SEVERAL WEEKS AFTER PLACEMENT OF A CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE, THE DEVICE BUTTON LOCKING ADAPTER CRACKED. REPORTEDLY, THE DEVICE WAS REPLACED (UNK PRODUCT/MFR). 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 M00581330 0000028882

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK