BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAPBAND

    MDR report key: 2494758 · Received March 8, 2012

    Report

    Report Number
    2494758
    Event Type
    Malfunction
    Date Received
    March 8, 2012
    Date of Event
    March 1, 2012
    Report Date
    March 8, 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

    A FEMALE WAS TAKEN TO SURGERY TO DETERMINE IF THERE WAS AN ISSUE WITH HER LAPBAND. PT HAD BEEN EXPERIENCING ISSUES WITH HER LAPBAND NOT RETAINING THE SALINE INJECTED INTO THE LAPBAND. UPON SURGICAL INSPECTION, THE SURGEON NOTED A LEAK DISTAL TO THE PORT. SURGON OPTED TO REMOVE THE LAPBAND AND REPLACE IT WITH ANOTHER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR