BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAPBAND

    MDR report key: 2491768 · Received February 16, 2012

    Report

    Report Number
    2491768
    Event Type
    Malfunction
    Date Received
    February 16, 2012
    Date of Event
    February 9, 2012
    Report Date
    February 16, 2012
    Manufacturer
    ALLERGAN, INC.
    Product Code
    LTI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE BARIATRIC SURGEON HAD SUSPECTED A POSSIBLE LEAK IN THE PT'S LAPBAND AS THERE HAD BEEN STRAW-LIKE COLORED FLUID PRESENT UPON ASPIRATION OF FLUID FROM HER LAPBAND DURING HER OFFICE VISITS WHEN ADJUSTMENTS WERE BEING MADE TO THE BAND. UPON SURGICAL INSPECTION, THE SURGEON NOTED A LEAK ALONG THE TUBING FROM THE PORT TO THE BAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAPBAND ALLERGAN LAGB 10.0CM LAPBAND LTI ALLERGAN, INC. B-2220 *

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR