BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STANDARD BALLOON REPLACEMENT G-TUBE

    MDR report key: 1211347 · Received October 22, 2008

    Report

    Report Number
    3005099803-2008-05457
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    September 20, 2008
    Report Date
    September 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNT
    PMA / PMN Number
    K951489
    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, IT HAS NOT BEEN RECEIVED FOR EVALUATION. THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON SEPTEMBER 24, 2008, THAT A STANDARD BALLOON REPLACEMENT G-TUBE WAS PLACED IN A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PROCEDURE IN 2008. ACCORDING TO THE COMPLAINANT, AT ABOUT 5 DAYS POST-PROCEDURE, "NUTRITION BACKFLOW WAS FOUND AT THE RX-PORT." IT WAS FURTHER REPORTED THAT THE DEVICE WAS REPLACED BY A DIFFERENT DEVICE (UNKNOWN PRODUCT/MANUFACTURER). NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STANDARD BALLOON REPLACEMENT G-TUBE KNT BOSTON SCIENTIFIC CORPORATION M00562161 0000605068

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK