BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM VG

    MDR report key: 1231117 · Received November 12, 2008

    Report

    Report Number
    2024601-2008-00845
    Event Type
    Malfunction
    Date Received
    November 12, 2008
    Date of Event
    October 7, 2008
    Report Date
    October 15, 2008
    Manufacturer
    COSTA RICA
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER II. ALLERGAN HAS RECEIVED THE PRODUCT; HOWEVER, THE ANALYSIS RESULTS ARE PENDING AT THIS TIME. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF LEAKAGE AS FOLLOWS: "DEFLATION OF THE BAND MAY OCCUR DUE TO LEAKAGE FROM THE BAND, THE PORT OF THE CONNECTOR TUBING."

    Description of Event or Problem · 1

    REPORTED AS: A LEAK. "A PORT/CRACKED TUBING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM VG DEVICE FOR TREATMENT OR MORBID OBESITY LTI COSTA RICA NA 1328926

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR