BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 1915201 · Received November 2, 2010

    Report

    Report Number
    2024601-2010-00891
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Date of Event
    August 23, 2010
    Report Date
    September 16, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. (B)(4). VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER II. ANALYSIS NOTED THE ACCESS PORT HAD AN UNIDENTIFIED OPENING WITH LEAKAGE. THE PORT TUBING CONTAINED A LINEAR OPENING WITH LEAKAGE AND STRIATIONS CONSISTENT WITH SURGICAL DAMAGE. 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 THAT THERE WAS AN EXPLANTED DEVICE IN THEIR POSSESSION THAT NEEDED TO BE RETURNED. NO ADDITIONAL INFO WAS PROVIDED. FURTHER FOLLOW-UP WITH THE HEALTH PROFESSIONAL NOTED "PORT EXPLANT DUE TO LEAK."

    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