BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM

    MDR report key: 1253014 · Received December 4, 2008

    Report

    Report Number
    2024601-2008-01033
    Event Type
    Injury
    Date Received
    December 4, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 19, 2008
    Manufacturer
    BIOENTERICS CORPORATION
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER UNKNOWN. 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. THE REPORTER WAS UNABLE TO SUPPLY THAT 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 ASSOCIATED WITH THIS REPORT. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. BAND SLIPPAGE IS A SURGICAL/PHYSIOLOGICAL COMPLICATION, AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF BAND SLIPPAGE AS FOLLOWS: "OVER-DISSECTION OF THE STOMACH DURING PLACEMENT MAY RESULT IN SLIPPAGE OR EROSION OF THE BAND AND REQUIRE REOPERATION." "THE DISSECTION SHOULD BE THE SAME SIZE AS THE BAND OR EVEN SMALLER TO REDUCE THE POSSIBILITY OF BAND AND/OR STOMACH SLIPPAGE."

    Description of Event or Problem · 1

    REPORTED AS "PATIENT HAS SUBSEQUENTLY REQUIRED A SECOND REVISION AFTER DEVELOPING A POSTERIOR PROLAPSE" FROM JOURNAL ARTICLE: "SYMMETRICAL POUCH DILATATION AFTER LAPAROSCOPIC ADJUSTABLE GASTER BANDING: INCIDENCE AND MANAGEMENT", WENDY A. BROWN, AT AL (2008) OBES SURG 18:1104-1108 SPRINGER SCIENCE.

    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 Required Intervention