BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND

    MDR report key: 3181360 · Received June 19, 2013

    Report

    Report Number
    3181360
    Event Type
    Malfunction
    Date Received
    June 19, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 19, 2013
    Manufacturer
    ALLERGAN
    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

    DURING A SCHEDULED LAPAROSCOPIC GASTRIC BANDING PORT REVISION, A PORT WAS REMOVED DUE TO BROKEN TUBING.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LAB BAND REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277936 LAP-BAND IMPLANT, INTRAGASTRIC LTI ALLERGAN * *

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR