BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM

    MDR report key: 1235196 · Received November 12, 2008

    Report

    Report Number
    2024601-2008-00864
    Event Type
    Injury
    Date Received
    November 12, 2008
    Date of Event
    September 15, 2004
    Report Date
    October 14, 2008
    Manufacturer
    COSTA RICA
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. 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. BASED ON THE PROBABLE IMPLANT DATE, THE TAPER TYPE IS ASSUMED TO BE A TAPER II. 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. MULTIPLE REQUESTS FOR FURTHER INFORMATION TO CLARIFY THE EVENT OF "MISCELLANEOUS" HAVE BEEN MADE. ALLERGAN HAS RECEIVED NO RESPONSE FROM THE AUTHORS. AS IT IS UNKNOWN AT THIS TIME IF THE REPORTED EVENT OF "MISCELLANEOUS" IS RELATED TO THE LAP-BAND SYSTEM, WE ARE REPORTING IT. ADDITIONALLY, IN THE ABSENCE OF A MORE SPECIFIC EVENT DESCRIPTION, WE HAVE OPTED TO CODE THE EVENT AS "SURGERY RELATED COMPLICATION/ OBSERVATION". DEVICE LABELING: "COMPLICATIONS WHICH MAY RESULT FROM THE USE OF THIS PRODUCT INCLUDE THE RISKS ASSOCIATED WITH THE MEDICATIONS AND METHODS UTILIZED IN THE SURGICAL PROCEDURE, THE RISKS ASSOCIATED WITH ANY SURGICAL PROCEDURE AND THE PATIENT'S DEGREE OF INTOLERANCE TO ANY FOREIGN OBJECT IMPLANTED IN THE BODY."

    Description of Event or Problem · 1

    REPORTED EVENT OF REHOSPITALIZATION DUE TO MISCELLANEOUS FROM JOURNAL ARTICLE "ONE-YEAR READMISSION RATES AT A HIGH VOLUME BARIATRIC SURGERY CENTER: LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING, LAPAROSCOPIC GASTRIC BYPASS, AND VERTICAL BANDED GASTROPLASTY-ROUX-EN Y GASTRIC BYPASS", J. SAUNDERS, ET AL (2008) OBES SURG 18: 1233-1240 SPRINGER SCIENCE. ALLERGAN'S APPROACH TO COMPLIANCE IS TO RESOLVE ALL DOUBT IN FAVOR OF REPORTING.

    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 NI Hospitalization| R