BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 1990665 · Received February 8, 2011

    Report

    Report Number
    2024601-2011-00100
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    October 1, 2010
    Report Date
    January 11, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER UNK. (B)(4). THE PRODUCT ASSOCIATED WITH THIS REPORT WILL NOT BE RETURNED. THE CONNECTOR TYPE CANNOT BE IDENTIFIED NOR AN ASSUMPTION MADE AS TO THE TYPE OF CONNECTOR ASSOCIATED WITH THIS COMPLAINT BECAUSE NO SERIAL NUMBER OR IMPLANT DATE WAS GIVEN. HEMORRHAGE, PAIN, AND REFLUX ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF HEMORRHAGE AS FOLLOWS: "ADVERSE EVENTS: SPECIFIC COMPLICATIONS OF LAPAROSCOPIC SURGERY CAN INCLUDE SPLEEN DAMAGE (SOMETIMES REQUIRING SPLENECTOMY) OR LIVER DAMAGE, BLEEDING FROM MAJOR BLOOD VESSELS, LUNG PROBLEMS, THROMBOSIS, AND RUPTURE OF THE WOUND." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF EPIGASTRIC PAIN AND REFLUX AS FOLLOWS: "FLUID WOULD BE REMOVED FROM THE SYSTEM IF THERE WERE SYMPTOMS OF EXCESSIVE RESTRICTION OR OBSTRUCTION, INCLUDING EXCESSIVE SENSE OF FULLNESS, HEARTBURN, REGURGITATION AND VOMITING." "ULCERATION, GASTRITIS, GASTROESOPHAGEAL REFLUX, HEARTBURN, GAS BLOAT, DYSPHAGIA, DEHYDRATION, CONSTIPATION AND WEIGHT REGAIN HAVE BEEN REPORTED AFTER GASTRIC RESTRICTION PROCEDURES."

    Description of Event or Problem · 1

    DOCTOR REPORTED EVENTS OF"CHRONIC BLOOD LOSS", "EPIGASTRIC PAIN", REFLUX, AND "CONNECTING TUBE WAS FOUND PENETRATING THE TRANSVERSE COLON" FROM ABSTRACT ENTITLED, "A RARE COMPLICATION OF AN ADJUSTABLE GASTRIC BANDING CONNECTING TUBE: MIGRATION AND PENETRATION INTO THE COLON", THE AMERICAN JOURNAL OF GASTROENTEROLOGY (2010) NO. 879, VOL. 105, SUPP. 1, PAGE S318.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization| R