BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1595410 · Received January 20, 2010

    Report

    Report Number
    1595410
    Event Type
    Malfunction
    Date Received
    January 20, 2010
    Date of Event
    January 15, 2010
    Report Date
    January 20, 2010
    Manufacturer
    ALLERGAN, INC.
    Product Code
    LTI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD LAP BAND PLACEMENT FOUR YEARS AGO. THE PHYSICIAN COULD NO LONGER FILL THE LAP BAND. THEREFORE, THE PATIENT HAD LAP BAND RECENTLY REPLACED. THE PHYSICIAN INVOLVED FEELS THE INITIAL BAND MALFUNCTIONED BECAUSE IT COULD NO LONGER BE FILLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * LAP BAND LTI ALLERGAN, INC. * 11878115

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR