BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2770238 · Received October 1, 2012

    Report

    Report Number
    2024601-2012-00959
    Event Type
    Malfunction
    Date Received
    October 1, 2012
    Date of Event
    August 30, 2012
    Report Date
    September 4, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER UNKNOWN. MEDWATCH SENT TO FDA ON: 10/01/2012. THE ACCESS PORT CONNECTOR ASSOCIATED WITH THIS REPORT HAS NOT BEEN RETURNED AND WAS DISCARDED AFTER SURGERY BY THE REPORTER. THE REPORTER OF THE COMPLAINT WAS ASKED TO INDICATE THE PRODUCT SERIAL NUMBER AND THE MODEL NUMBER. THE INFORMATION HAS NOT YET BEEN RECEIVED BY ALLERGAN. BASED UPON THE IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS EITHER A TAPER II OR A RAPIDPORT EZ TRAIN RELIEF. THE CONNECTOR TYPE CANNOT BE IDENTIFIED NOR AN ASSUMPTION BE MADE AS TO THE TYPE OF CONNECTOR ASSOCIATED WITH THIS COMPLAINT BECAUSE NO SERIAL NUMBER WAS GIVEN. ALLERGAN WILL NOT RECEIVE THE PRODUCT. THEREFORE NO ANALYSIS OR TESTING CAN BE DONE. NO ADDITIONAL INFORMATION HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER OR MODEL NUMBER, EVENT DATE, IMPLANT DATE, DIAGNOSTIC TESTING, PATIENT WEIGHT OR HISTORY. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF LEAKAGE AS FOLLOWS: "DEFLATION OF THE BAND MAY OCCUR DUE TO LEAKAGE FROM THE BAND, THE PORT OR THE CONNECTOR TUBING."

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL AT HOSPITAL REPORTED TO ALLERGAN REPRESENTATIVE A PORT REPLACEMENT WAS PERFORMED FOR AN ALLEGED LEAK. INVESTIGATION IN PROGRESS. FOLLOW-UP FINDINGS: PORT WAS EXPLANTED DUE TO A SUSPECTED LEAK OR TUBE DISCONNECTION. NO SERIAL NUMBER OR MODEL NUMBER WAS PROVIDED TO ALLERGAN. THE DEVICE WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR