BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75CM

    MDR report key: 3000128 · Received February 14, 2013

    Report

    Report Number
    2024601-2013-00078
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    December 15, 2012
    Report Date
    January 25, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT YET BEEN RETURNED. BASED UPON THE SERIAL NUMBER AN IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUME TO BE A TAPER I. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. VISUAL EXAMINATION MAY CONFIRM OR DETERMINE ANOTHER CONNECTOR TYPE ASSOCIATED WITH THIS PORT. 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. 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

    REPORTED AS "DISADAPTATION OF THE PORT." THE LEAK WAS RESOLVED WITH THE REMOVAL AND REPLACEMENT OF THE ACCESS PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64607 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75CM LTI ALLERGAN NA S00LB002

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR