BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM

    MDR report key: 1011327 · Received March 10, 2008

    Report

    Report Number
    2024601-2008-00110
    Event Type
    Malfunction
    Date Received
    March 10, 2008
    Date of Event
    February 11, 2008
    Report Date
    February 11, 2008
    Manufacturer
    COSTA RICA
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. THE PROD ASSOCIATED WITH THIS REPORT HAS NOT YET BEEN RETURNED. BASED UPON THE IMPLANT DATE AND SERIAL NUMBER PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PROD FOR ANALYSIS. VISUAL EXAMINATION MAY CONFIRM OR DETERMINE ANOTHER CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. INADEQUATE WEIGHT LOSS IS ADDRESSED IN THE LABELING. ALLERGAN DOES NOT GUARANTEE THAT EVERY PT WILL ACHIEVE DESIRED WEIGHT LOSS. 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: "THE PT'S WEIGHT LOSS HAD TAPERED OFF. THE FLUID IN THE BAND WAS CHECKED AND IT WAS NOTED THAT THE FLUID WAS LEAKING. THE BAND WAS REMOVED AND REPLACED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM DEVICE FOR TREATMENT OF MORBID OBESITY LTI COSTA RICA NA 1132066

    Patients

    Seq Age Sex Outcome Treatment
    1