BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2191380 · Received July 27, 2011

    Report

    Report Number
    2024601-2011-00613
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 1, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER II. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. NO ADD'L INFO HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER OF THE DEVICE. 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

    ALLERGAN REP REPORTED AN ALLEGED LAP-BAND PORT LEAK. THE PT HAD SEEN THE SURGEON FOR AN ADJUSTMENT FILL AND REPORTED FEELING NO RESTRICTION. DURING THIS CONSULTATION, THE SURGEON TRIED TO REMOVE EXISTING SALINE FROM THE DEVICE BUT THERE WAS LESS FLUID THAN THE NOTES (FROM PRIOR ADJUSTMENT APPOINTMENTS) HAD INDICATED. NO DIAGNOSTIC TESTING WAS USED TO DETERMINE THE LOCATION OF THE LEAK. THE DEVICE WAS REMOVED AND REPLACED. THE DEVICE RETURN TO ALLERGAN FOR PRODUCT ANALYSIS IS CURRENTLY PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR