BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM

    MDR report key: 1051430 · Received May 20, 2008

    Report

    Report Number
    2024601-2008-00272
    Event Type
    Malfunction
    Date Received
    May 20, 2008
    Date of Event
    April 21, 2008
    Report Date
    April 21, 2008
    Manufacturer
    BIOENTERICS CORP.
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER UNKNOWN. MEDWATCH SENT TO FDA ON: 05/20/08. PER THE REPORTER OF THE COMPLAINT, THE PRODUCT IS NOT AVAILABLE FOR RETURN. THE REPORTER WAS ASKED TO INDICATE THE PRODUCT SERIAL NUMBER, DATE OF EVENT, IMPLANT DATE AND EXPLANT DATE. THE INFO HAS NOT YET BEEN RECEIVED BY ALLERGAN. THE CONNECTOR TYPE CANNOT BE IDENTIFIED NOR AN ASSUMPTION MADE AS TO THE TYPE OF CONNECTOR ASSOCIATED WITH THIS COMPLAINT BECAUSE NO SERIAL NUMBER OR IMPLANT DATE WAS GIVEN. ALLERGAN WILL NOT RECEIVE THE PRODUCT. THEREFORE, NO ANALYSIS OR TESTING CAN BE DONE. DEVICE LABELING ADDRESSED 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 A DAMAGED PORT, "A LEAK".

    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 CORP. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI