BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM

    MDR report key: 1304645 · Received February 3, 2009

    Report

    Report Number
    2024601-2009-00069
    Event Type
    Injury
    Date Received
    February 3, 2009
    Date of Event
    January 15, 2003
    Report Date
    January 14, 2009
    Manufacturer
    BIOENTERICS CORP
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER UNKNOWN. 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. SINCE ALLERGAN HAS NOT YET RECEIVED THIS INFO, THE CONNECTOR TYPE CANNOT BE IDENTIFIED NOR AN ASSUMPTION MADE AS TO THE TYPE OF CONNECTOR ASSOCIATED WITH THIS COMPLAINT. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE. ALLERGAN HAD NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. PULMONARY COMPLICATIONS ARE A SURGICAL/PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. 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 PULMONARY COMPLICATION FROM JOURNAL ARTICLE "LAPAROSCOPIC ADJUSTABLE GASTRIC BAND FOR MORBID OBESITY-LOCAL EXPERIENCE IN AL-AHSA REGION OF SAUDI ARABIA", KUWAIT MEDICAL JOURNAL 2008, 41 (4): 301-303.

    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 BIOENTERICS CORP NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention