BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAB-BAND ADJUSTABLE GASTRIC BANDING SYSTEM

    MDR report key: 1150895 · Received September 2, 2008

    Report

    Report Number
    2024601-2008-00535
    Event Type
    Malfunction
    Date Received
    September 2, 2008
    Date of Event
    August 6, 2008
    Report Date
    August 6, 2008
    Manufacturer
    COSTA RICA
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER II. A LEAK TEST AND FILL INSPECTION REVEAL NO LEAKAGE TO THE DEVICE. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF LEAKAGE AND DISPLACEMENT AS FOLLOWS: "DEFLATION OF THE BAND MAY OCCUR DUE TO LEAKAGE FROM THE BAND, THE PORT OR THE CONNECTOR TUBING." "FAILURE TO SECURE THE PORT PROPERLY MAY RESULT IN ITS SUBSEQUENT DISPLACEMENT AND NECESSITATE REOPERATION."

    Description of Event or Problem · 1

    F/U WITH THE DOCTOR REVEALS "A PORT LEAK AND DISPLACEMENT WITH PORT REMOVAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAB-BAND ADJUSTABLE GASTRIC BANDING SYSTEM DEVICE FOR TREATMENT OF MORBID OBESITY LTI COSTA RICA NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1