BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 2052091 · Received March 1, 2011

    Report

    Report Number
    2024601-2011-00133
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    August 19, 2010
    Report Date
    October 14, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. MEDWATCH SENT TO FDA ON: (B)(4) 2011. THE PRODUCT ASSOCIATED WITH THIS REPORT HAS BEEN DISCARDED. BASED UPON THE SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. 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

    HOSP STAFF REPORTED AN ALLEGED LEAK WITH A LAP-BAND PORT. THE PROBLEM WAS FIRST NOTICED WHEN THE PT PRESENTED WITH NO RESTRICTION. THE LEAK WAS CONFIRMED BY BAND ASPIRATION OVER MULTIPLE OFFICE VISITS. THE PORT WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA 1730994

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR