BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE) NON US

    MDR report key: 1211025 · Received October 23, 2008

    Report

    Report Number
    2024601-2008-00817
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    September 30, 2008
    Report Date
    October 1, 2008
    Manufacturer
    COSTA RICA
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. MEDWATCH SENT TO FDA ON: 23/OCT/2008. THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT YET BEEN RETURNED. BASED UPON THE SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. VISUAL EXAMINATION MAY CONFIRM OR DETERMINE ANOTHER CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE NO ANALYSIS OR TESTING HAS BEEN DONE. EROSION AND INFECTION ARE SURGICAL /PHYSIOLOGICAL COMPLICATIONS, AND ANALYSIS OF DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. 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." DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF AN INFECTION AS FOLLOWS: "INFECTION CAN OCCUR IN THE IMMEDIATE POST-OPERATIVE PERIOD OR YEARS AFTER INSERTION OF THE DEVICE. IN THE PRESENCE OF INFECTION OR CONTAMINATION, REMOVAL OF THE DEVICE IS INDICATED."

    Description of Event or Problem · 1

    REPORTED AS: "2008 - PORT SITE INFECTION - GASTROSCOPY 2008 - EROSION SEEN - APL REMOVED. TO BE REPLACED AT A LATER DATE." FOLLOW-UP WITH THE DOCTOR'S OFFICE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE) NON US DEVICE FOR TREATMENT OF MORBID OBESITY LTI COSTA RICA NA 1384600

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention