BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INAMED LAP-BAND SYSTEM

    MDR report key: 1013904 · Received February 21, 2008

    Report

    Report Number
    1013904
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    December 17, 2007
    Report Date
    January 30, 2008
    Manufacturer
    ALLERGAN, INC.
    Product Code
    LTI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD LAPAROSCOPIC GASTRIC BANDING DONE LAST YEAR. THE BAND FAILED AND CAUSED A LEAK. THE PATIENT HAD THE BAND REMOVED 6 MONTHS LATER AND REPLACED WITH SAME TYPE OF IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INAMED LAP-BAND SYSTEM GASTRIC BAND LTI ALLERGAN, INC. B-2220 NOT DOCUMENTED

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR