BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 3133122 · Received May 24, 2013

    Report

    Report Number
    2024601-2013-00456
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    April 30, 2013
    Report Date
    April 30, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTER OF THE COMPLAINT WAS ASKED FOR THE PRODUCT SERIAL NUMBER, DATE OF EVENT AND IMPLANT 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. THE DEVICE WAS NOT EXPLANTED THEREFORE NO ANALYSIS OR TESTING HAS BEEN DONE. OBSTRUCTION, ABDOMINAL PAIN, VOMIT, OBSTIPATION, DISTENDED ABDOMEN, AND DILATION OF THE SMALL BOWEL ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. 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 THROUGHLY. 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." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF ABDOMINAL PAIN AS FOLLOWS: "THERE WERE ADDITIONAL OCCURRENCES OF THESE EVENTS THAT WERE CONSIDERED TO BE NON-SERIOUS. OTHER ADVERSE EVENTS CONSIDERED RELATED TO THE LAP-BAND SYSTEM THAT OCCURRED IN FEWER THAN 1% OF SUBJECTS INCLUDED: ABDOMINAL PAIN, CHEST PAIN, INCISION PAIN AND PORT SITE PAIN." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF VOMIT AS FOLLOWS: "NAUSEA AND VOMITING MAY OCCUR, PARTICULARLY IN THE FIRST FEW DAYS AFTER SURGERY AND WHEN THE PT EATS MORE THAN RECOMMENDED." DEVICE LABELING ADDRESSES THE POTENTIAL OF ADVERSE EVENTS AS FOLLOWS: "IT IS IMPLANT 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

    DOCTOR REPORTED EVENTS OF ABDOMINAL PAIN, OBSTIPATION, VOMITING, DISTENDED ABDOMEN, SMALL BOWEL OBSTRUCTION, AND "...DILATION OF THE PROXIMAL SMALL BOWEL, AND COLLAPSE DISTALLY" FROM JOURNAL ARTICLE: "SMALL BOWEL OBSTRUCTION FROM LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING CONNECTING TUBE", ANZ JOURNAL OF SURGERY, (2013 MAY) VOL. 83, NO. 5, PP. 389-9. MANUFACTURER OF DEVICE IS UNK. 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
    230982 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R