BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0 CM NON US

    MDR report key: 1241884 · Received November 18, 2008

    Report

    Report Number
    2024601-2008-00915
    Event Type
    Malfunction
    Date Received
    November 18, 2008
    Date of Event
    January 15, 2008
    Report Date
    October 21, 2008
    Manufacturer
    COSTA RICA
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER UNKNOWN. THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS, AS WELL AS INDICATE THE PRODUCT SERIAL NUMBER, DATE OF EVENT, IMPLANT DATE AND EXPLANT DATE. SINCE ALLERGAN HAS NOT YET RECEIVED THIS INFORMATION, THE CONNECTOR TYPE CANNOT BE IDENTIFIED NOR AN ASSUMPTION MADE AS THE TYPE OF CONNECTOR ASSOCIATED WITH THIS COMPLAINT. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. DEVICE LABELING: "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 EVENT OF "PORT DISCONNECTION OR RUPTURE" REQUIRING REOPERATION FROM JOURNAL ARTICLE: "BAND AND PORT-RELATED MORBIDITY AFTER BARIATRIC SURGERY: AN UNDERESTIMATED PROBLEM". M.V. LAUNAY-SAVARY, ET AL (2008) OBES SURG 18:1406-1410 SPRINGER SCIENCE. ALLERGAN'S APPROACH TO COMPLIANCE IS TO RESOLVE ALL DOUBT IN FAVOR OF REPORTING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI