BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 1854493 · Received September 3, 2010

    Report

    Report Number
    2024601-2010-00724
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    June 9, 2009
    Report Date
    August 4, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER UNKNOWN. (B)(4). THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS AS WELL AS INDICATE THE PRODUCT SERIAL NUMBER, DATE OF EVENT, IMPLANT DATE AND EXPLANT DATE. SINCE ALLERGAN HAS NOT YET RECEIVED THIS INFORMATION, THE CONNECTOR TYPE CANNOT BE IDENTIFIED NOR AN ASSUMPTION MADE AS TO THE TYPE OF CONNECTOR ASSOCIATED WITH THIS COMPLAINT. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. DEVICE LABELING ADDRESSES THE EVENT OF LEAK 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

    DOCTOR REPORTED EVENTS OF "RUPTURED BAND", "TUBING DISCONNECTION FROM PORT", AND "LEAK AT PORT SITE" FROM JOURNAL ARTICLE: "REASONS AND OUTCOMES OF LAPAROSCOPIC REVISIONAL SURGERY AFTER LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING FOR MORBID OBESITY", SURGERY FOR OBESITY AND RELATED DISEASES 6 (2010) 391-398. THIS MEDWATCH REPRESENTS THE 8 PATIENTS LISTED IN TABLE 2 OF THE ARTICLE WHO WERE DIAGNOSED WITH "RUPTURED BAND", "TUBING DISCONNECTION FROM PORT", AND "LEAK AT PORT SITE." IT IS ALLERGAN'S APPROACH TO COMPLIANCE TO RESOLVE ALL DOUBT IN FAVOR OF REPORTING.

    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 Required Intervention