BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE

    MDR report key: 1082525 · Received July 22, 2008

    Report

    Report Number
    3005099803-2008-01227
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    June 23, 2008
    Report Date
    June 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNK, THEREFORE, THE MFR DATE CANNOT BE DETERMINED. ALTHOUGH THE COMPLAINANT HAS INDICATED THAT THE SUSPECT DEVICE IS BEING RETURNED FOR EVALUATION, IT HAS NOT BEEN REC'D. THE DEVICE EVALUATION HAS NOT BEEN PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON 06/24/08 THAT A LOW PROFILE GASTROSTOMY DEVICE WAS PLACED IN 2008. ACCORDING TO THE COMPLAINANT, THE BALLOON WAS NOTED TO BE OUTSIDE THE PT AND WAS ALSO NOTED TO HAVE A PIN HOLE. A REPLACEMENT PEG PROCEDURE WAS PERFORMED WITH A SECOND LOW PROFILE GASTROSTOMY DEVICE. THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THE 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