BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM

    MDR report key: 1182327 · Received September 29, 2008

    Report

    Report Number
    2024601-2008-00749
    Event Type
    Malfunction
    Date Received
    September 29, 2008
    Date of Event
    September 2, 2008
    Report Date
    September 2, 2008
    Manufacturer
    BIOENTERICS CORPORATION
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNKNOWN. MEDWATCH SENT TO FDA ON: 29/SEP/08. THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT BEEN RETURNED FOR ANALYSIS. NO INFORMATION REGARDING SERIAL NUMBER O IMPLANT DATE WAS OBTAINABLE BY THE REPORTER, THEREFORE THE CONNECTOR TYPE IS UNKNOWN. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE NO ANALYSIS OR TESTING HAS BEEN DONE. NO ADDITIONAL INFORMATION HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER OR THE EXPLANT DATE. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF LEAKAGE AS FOLLOWS: "DEFLATION OF THE BAND MAY OCCUR DUE TO LEAKAGE FROM THE BAND, THE PORT OF THE CONNECTOR TUBING".

    Description of Event or Problem · 1

    REPORTED AS, "... HEARD OF PORT THAT WAS REPLACED DUE TO LEAKAGE." NO ADDITIONAL INFORMATION IS AVAILABLE. ALLERGAN'S APPROACH TO COMPLIANCE IS TO RESOLVE ALL DOUBTS IN FAVOR OF REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM DEVICE FOR TREATMENT OF MORBID OBESITY LTI BIOENTERICS CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI