BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2890685 · Received December 21, 2012

    Report

    Report Number
    2024601-2012-01356
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    November 28, 2012
    Report Date
    December 4, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 INFO 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 OR IMPLANT DATE WAS GIVEN. 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. OBSTRUCTION IS A SURGICAL/PHYSICAL COMPLICATION AND ANALYSIS OF DEVICE GENERALLY DOES NOT ASSIST. ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF OBSTRUCTION AS FOLLOWS: "OBSTRUCTION OF STOMAS HAS BEEN REPORTED AS BOTH AN EARLY AND A LATE COMPLICATION OF THIS PROCEDURE. THIS CAN BE CAUSED BY EDEMA, FOOD, IMPROPER INITIAL CALIBRATION, BAND SLIPPAGE, POUCH TORSION, OR PT NONCOMPLIANCE REGARDING CHOICE AND CHEWING OF FOOD." "PTS MUST BE CAUTIONED TO CHEW THEIR FOOD THOROUGHLY. PTS WITH DENTURES MUST BE PARTICULARLY CAREFUL TO CUT THEIR FOOD INTO SMALL PIECES. FAILURE TO FOLLOW THESE PRECAUTIONS MAY RESULT IN VOMITING, STOMAL IRRITATION AND EDEMA, POSSIBLY EVEN OBSTRUCTION."

    Description of Event or Problem · 1

    REPORTED EVENTS OF INTOLERANCE, BAND SLIPPAGE, EROSION, INFECTION, AND "COMPLETE BLOCKAGE" FROM JOURNAL ARTICLE: "LAPAROSCOPIC SLEEVE GASTRECTOMY (LSG) - A GOOD BARIATRIC OPTION FOR FAILED LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING (LAGB): A REVIEW OF 90 PTS", OBES SURG, DOI 10.10007/S11695-012-0825-7. MANUFACTURER OF DEVICE IS UNK. IT IS ALLERGAN'S APPROACH TO COMPLIANCE TO RESOLVE ALL DOUBT IN FAVOR OF REPORTING. THIS MEDWATCH REPRESENTS THE 3 CASES OF "BLOCKAGE".

    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 NO INFO