BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 3912774 · Received May 14, 2014

    Report

    Report Number
    2024601-2014-00261
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    February 19, 2014
    Report Date
    April 23, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    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, SERIAL NUMBER AND IMPLANT DATE 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.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED, "LEAK IN PORT." "PATIENT NOTICED INITIAL RESTRICTION WITH BAND ADJUSTMENT BUT THIS SOON DISAPPEARS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288066 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA 2465198

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR METFORMIN| BECLOVENT| PULMICORT| NORVASC| MINIZIDE| ALTACE| TYLENOL 3| CYMBALTA| LOSEPRAZOL| MIRENA IUD| SYNTHROID| CELEBREX| TYLENOL| VICTOZA| NAPROXEN