BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM ACCESS PORT I

    MDR report key: 1150889 · Received September 2, 2008

    Report

    Report Number
    2024601-2008-00531
    Event Type
    Malfunction
    Date Received
    September 2, 2008
    Date of Event
    July 29, 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
    IN, 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. ANALYSIS OF THE DEVICE ALSO FOUND AN OPENING IN THE PORT TUBING BETWEEN THE STAINLESS STEEL CONNECTOR AND THE INJECTION SITE. THE OPENING IS CONSISTENT WITH PUNCTURE BY A NEEDLE AND MAY BE SOURCE OF THE LEAKAGE. ANOTHER BREAKAGE WAS NOTED IN THE BAND TUBING WHICH APPEARS TO HAVE BEEN CAUSED BY A SHARP INSTRUMENT. THIS BREAKAGE MAY HAVE BEEN MADE TO FACILITATE REMOVAL OF THE DEVICE, AND MAY NOT BE THE CAUSE OF THE LEAKAGE. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF LEAKAGE AS FOLLOWS: 'DEFLATION OF THE BAND MAY OCCUR DUE TO LEAKAGE FROM THE BAND, THE PORT OR THE CONNECTOR TUBING."

    Description of Event or Problem · 1

    REPORTED AS PORT LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM ACCESS PORT I DEVICE FOR TREATMENT OF MORBID OBESITY LTI COSTA RICA NA 1398836

    Patients

    Seq Age Sex Outcome Treatment
    1