BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, ADJUSTABLE GASTRIC BANDING

    MDR report key: 2032432 · Received March 11, 2011

    Report

    Report Number
    2032432
    Event Type
    Malfunction
    Date Received
    March 11, 2011
    Date of Event
    February 12, 2011
    Report Date
    March 11, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    THE LAP BAND HAD BEEN DETERMINED BY THE SURGEON TO HAVE FAILED AND WAS DEFECTIVE. IT WAS REMOVED FROM THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM, ADJUSTABLE GASTRIC BANDING GASTRIC LAP BAND LTI ALLERGAN LAGB VC *

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR