BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM

    MDR report key: 2081964 · Received April 5, 2011

    Report

    Report Number
    2024601-2011-00207
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    September 22, 2010
    Report Date
    March 8, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. MEDWATCH SEND TO FDA ON: (B)(4) 2011. 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 HAS NOT BEEN COMPLETED 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 OR THE CONNECTOR TUBING."

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED AN ALLEGED LAP-BAND LEAK. THE SURGEON NOTED THERE WAS A "LEAK ON THE BALLOON." THIS EVENT WAS CONFIRMED BY THE SURGEON WHEN THE PATIENT WENT IN FOR AN ADJUSTMENT FILL AND THE SURGEON WAS NOT ABLE TO RETRIEVE ANY FLUID. THE PORT WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM LTI ALLERGAN NA 610938

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR