BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM VG

    MDR report key: 3772227 · Received January 2, 2014

    Report

    Report Number
    2024601-2013-01053
    Event Type
    Malfunction
    Date Received
    January 2, 2014
    Date of Event
    November 29, 2013
    Report Date
    December 9, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. THE DEVICE HAS NOT YET BEEN RECEIVED BY ALLERGAN. BASED UPON THE MODEL NUMBER AND SERIAL NUMBER PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE NO ANALYSIS OR TESTING HAS BEEN DONE. NO ADDITIONAL INFORMATION HAS BEEN REPORTED TO ALLERGAN REGARDING THE IMPLANT DATE, EXPLANT DATE, DIAGNOSTIC TESTING OR FULL PATIENT DATE OF BIRTH.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED AS "SYSTEM LEAKAGE." THE LEAKAGE IS NOTED AT THE TUBING AROUND THE STAINLESS STEEL CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2802 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM VG LTI ALLERGAN N/A 2080981

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR NONE NOTED ON REPORT.