BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 4173354 · Received October 10, 2014

    Report

    Report Number
    2024601-2014-00561
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 15, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 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. NO ADDITIONAL INFO HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER OR CATALOG NUMBER.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED EXPLANT OF A LAP-BAND PORT DUE TO A LEAK. THE LEAK WAS NOTICED DURING THE PATIENT'S FIRST ADJUSTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643026 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE) LTI LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR