BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM

    MDR report key: 1143673 · Received August 29, 2008

    Report

    Report Number
    2024601-2008-00521
    Event Type
    Injury
    Date Received
    August 29, 2008
    Date of Event
    May 15, 2007
    Report Date
    August 5, 2008
    Manufacturer
    BIOENTERICS CORPORATION
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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 INFORMATION 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. BAND SLIPPAGE IS A SURGICAL/PHYSIOLOGICAL COMPLICATION, AND ANALYSIS OF DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF 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 IN: SURGERY FOR RELATED DISEASES JOURNAL ARTICLE, 04/2008 EDITION: "MANAGEMENT OF SLIPPED ADJUSTABLE GASTRIC BAND SLIPPAGE IN PATIENTS." FOLLOW UP REVEALS: "NO INFORMATION FROM THE PHYSICIAN AFTER 3 ATTEMPTS TO CONTACT FOR MORE INFORMATION."

    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