BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 3841157 · Received May 13, 2014

    Report

    Report Number
    2024601-2014-00286
    Event Type
    Injury
    Date Received
    May 13, 2014
    Date of Event
    July 12, 2013
    Report Date
    April 16, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL CATALOG #LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE). 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. THE CONNECTOR TYPE CANNOT BE IDENTIFIED NOR AN ASSUMPTION MADE AS TO THE TYPE OF CONNECTOR ASSOCIATED WITH THIS COMPLAINT BECAUSE NO SERIAL NUMBER AND/OR IMPLANT DATE WAS GIVEN. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE NO ANALYSIS OR TESTING HAS BEEN DONE. MULTIPLE REQUESTS FOR FURTHER INFORMATION HAVE BEEN MADE. ALLERGAN HAS RECEIVED NO RESPONSE FROM THE AUTHORS. INFECTION IS A SURGICAL/PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    REPORTED EVENT OF INFECTION FROM JOURNAL ARTICLE: "BENEFITS AND RISKS OF BARIATRIC SURGERY IN PATIENTS AGED MORE THAN 60 YEARS", SURGERY FOR OBESITY AND RELATED DISEASES OFFICIAL JOURNAL OF AMERICAN SOCIETY FOR BARIATRIC SURGERY, (JANUARY 09, 2014). ELECTRONIC PUBLICATION DATE: JANUARY 09, 2014. ALTHOUGH THE MANUFACTURER OF THE DEVICE IS UNKNOWN, IT IS ALLERGAN'S APPROACH TO COMPLIANCE TO RESOLVE ALL DOUBT IN FAVOR OF REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285343 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention