BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM

    MDR report key: 1051498 · Received April 23, 2008

    Report

    Report Number
    2024601-2008-00281
    Event Type
    Injury
    Date Received
    April 23, 2008
    Date of Event
    September 13, 2007
    Manufacturer
    COSTA RICA
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT BEEN RETURNED. BASED UPON THE IMPLANT DATE PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. ALLERGAN HAS NOT RECEIVED THE PRODUCT FOR ANALYSIS. VISUAL EXAMINATION MAY CONFIRM OR DETERMINE ANOTHER CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. NO ADD'L INFO HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER. DEVICE LABELING ADDRESSES THE REPORTED ALLEGED EVENTS AS FOLLOWS "ADVERSE EVENTS" AS, "IT IS IMPORTANT TO DISCUSS ALL POSSIBLE COMPLICATIONS AND ADVERSE EVENTS WITH YOUR PT. 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 PT'S DEGREE OF INTOLERANCE TO ANY FOREIGN OBJECT IMPLANTED IN THE BODY."

    Description of Event or Problem · 1

    PT'S LAWYER REPORTED "EXPERIENCING PAIN AND SYMPTOMS DUE TO THE DEFECTIVE CONDITION OF THE AFOREMENTIONED LAP-BAND SYSTEM." ADDITIONAL INFO NOTED VARIED INJURIES SUCH AS: SEVERE PAIN, SICK, SORE, LAME, DISABLED, SHOCK, PERMANENT INJURIES, PHYSICAL AND MENTAL ANGUISH. ALLERGAN IS UNABLE TO CONFIRM THE ALLEGED EVENTS WITH THE PT'S SURGEON THEREFORE, ALLERGAN'S APPROACH TO COMPLIANCE IS TO RESOLVE ALL DOUBTS 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 Required Intervention| S