BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM

    MDR report key: 1004028 · Received February 26, 2008

    Report

    Report Number
    2024601-2008-00080
    Event Type
    Injury
    Date Received
    February 26, 2008
    Date of Event
    September 15, 2006
    Report Date
    January 29, 2008
    Manufacturer
    COSTA RICA
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT BEEN RETURNED. NO CONTACT INFORMATION IS AVAILABLE FOR THE REPORTER OF THE COMPLAINT. THEREFORE, THE REPORTER CAN NOT BE ASKED TO RETURN THE PRODUCT FOR ANALYSIS AND/OR INDICATE THE PRODUCT SERIAL NUMBER. BASED UPON THE IMPLANT DATE PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. VISUAL EXAMINATION MAY CONFIRM OR DETERMINE ANOTHER CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. THE INITIAL REPORT OF THE ALLEGED EVENT WAS SUBMITTED ANONYMOUS AND NO CONTACT INFORMATION WAS PROVIDED FOR A POSSIBLE FOLLOW-UP. ALL ATTEMPTS TO CONTACT THE REPORTER WERE UNSUCCESSFUL. INFECTION 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 ADDRESSED THE POSSIBLE OUTCOME OF AN INFECTION AS FOLLOWS: "INFECTION CAN OCCUR IN THE IMMEDIATE POST-OPERATIVE PERIOD OF 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 "INFECTION UNDER ADJUSTMENT BOX (PORT), THE LAP-BAND TAKEN OUT."

    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 COSTA RICA NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention