BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APL LOW PROFILE

    MDR report key: 1595382 · Received January 22, 2010

    Report

    Report Number
    1595382
    Event Type
    Malfunction
    Date Received
    January 22, 2010
    Date of Event
    October 26, 2009
    Report Date
    January 22, 2010
    Manufacturer
    ALLERGAN, INC.
    Product Code
    LTI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LAPAROSCOPIC IMPLANT OF LAP BAND WAS IN PLACE FOR FOURTEEN MONTHS. SURGEON SAYS THERE IS LEAKING FROM THE BAND TUBING. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION AND TESTING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR