BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM

    MDR report key: 1192343 · Received September 25, 2008

    Report

    Report Number
    2024601-2008-00747
    Event Type
    Injury
    Date Received
    September 25, 2008
    Date of Event
    April 8, 2007
    Report Date
    September 15, 2008
    Manufacturer
    BIOENTRICS CORP
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. THE PROD ASSOCIATED WITH THIS REPORT HAS NOT YET BEEN RETURNED. BASED UPON THE IMPLANT DATE PROVIDED BY THE RPTR, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. VISUAL EXAMINATION MAY CONFIRM OR DETERMINE ANOTHER CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. NO CONTACT INFO, FOR THE PT AND/OR PHYSICIAN, HAS BEEN MADE AVAILABLE TO ALLERGAN. THE RETURN OF THE DEVICE CAN NOT BE REQUESTED. ALLERGAN HAS NOT REC'D THE PROD AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. EROSION IS A SURGICAL/PHYSIOLOGICAL COMPLICATION, AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF EROSION AS FOLLOWS: "THERE IS A RISK OF BAND EROSION INTO STOMACH TISSUE. RE-OPERATION TO REMOVE THE DEVICE IS REQUIRED. CAUTION: AS WITH OTHER GASTROPLASTY SURGERIES, PARTICULAR CARE MUST BE TAKEN DURING DISSECTION AND DURING IMPLANTATION OF THE DEVICE TO AVOID DAMAGE TO THE GASTROINTESTINAL TRACT. ANY DAMAGE TO THE STOMACH DURING THE PROCEDURE MAY RESULT IN EROSION OF THE DEVICE INTO THE GI TRACT."

    Description of Event or Problem · 1

    REPORTED TO ALLERGAN BY FDA AS FOLLOWS: "VOLUN. 2008: INAMED LAP BAND EROSION. STOMACH DAMAGED. IMMEDIATE SURGERY FOR REMOVAL AND REPAIR OF STOMACH. DATES OF USE 2008-2007. SERIAL # CONFIDENTIAL. RPTR: PT." NO CONTACT INFO, FOR A F/U AND/OR DEVICE RETURN REQUEST, AVAILABLE FOR THE PT AND/OR THE PHYSICIAN.

    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 BIOENTRICS CORP NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention