BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2772341 · Received October 2, 2012

    Report

    Report Number
    2024601-2012-01032
    Event Type
    Malfunction
    Date Received
    October 2, 2012
    Date of Event
    September 4, 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 UNK. (B)(4). 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, DATE OF EVENT AND IMPLANT DATE. THE INFO HAS NOT YET BEEN RECEIVED BY ALLERGAN. 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 OR IMPLANT DATE WAS GIVEN. THE REPORTER DISCARDED THE DEVICE WHEN IT WAS EXPLANTED AND IT IS NO LONGER AVAILABLE FOR RETURN. THEREFORE, ALLERGAN WILL NOT RECEIVE IT AND NO ANALYSIS OR TESTING WILL BE DONE. THE FACILITY HAS DECLINED TO PROVIDE ALLERGAN ADDITIONAL INFO REGARDING THE SERIAL NUMBER OR MODEL NUMBER, EVENT DATE, IMPLANT DATE, EXPLANT DATE, EXPLANT SURGEON, DIAGNOSTIC TESTING, PT'S NAME, DATE OF BIRTH, SEX, WEIGHTS 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 REP A PORT REPLACEMENT WAS PERFORMED FOR AN ALLEGED LEAK. INVESTIGATION IN PROGRESS. FOLLOW-UP FINDINGS: THE FACILITY HAS DECLINED TO PROVIDE FURTHER INFO REGARDING THIS REPORTED ALLEGED EVENT.

    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 NI