BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2756273 · Received September 19, 2012

    Report

    Report Number
    2024601-2012-00856
    Event Type
    Injury
    Date Received
    September 19, 2012
    Date of Event
    September 4, 2011
    Report Date
    August 21, 2012
    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

    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 INFORMATION 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 HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. BAND SLIPPAGE, OBSTRUCTION, NAUSEA, AND VOMITING 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 EVENTS OF BAND SLIPPAGE AND OBSTRUCTION AS FOLLOWS: "BAND SLIPPAGE AND/OR POUCH DILATATION CAN OCCUR. GASTROESOPHAGEAL REFLUX, NAUSEA AND/OR VOMITING WITH EARLY OR MINOR SLIPPAGE MAY BE SUCCESSFULLY RESOLVED BY BAND DEFLATION IN SOME CASES. MORE SERIOUS SLIPPAGES MAY REQUIRE BAND REPOSITIONING AND/OR REMOVAL. IMMEDIATE RE-OPERATION TO REMOVE THE BAND IS INDICATED IF THERE IS TOTAL STOMA-OUTLET OBSTRUCTION THAT DOES NOT RESPOND TO BAND DEFLATION OR IF THERE IS ABDOMINAL PAIN." "CAUTION: OVER-DISSECTION OF THE STOMACH DURING PLACEMENT MAY RESULT IN SLIPPAGE OR EROSION OF THE BAND AND REQUIRE REOPERATION." "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 PATIENT NONCOMPLIANCE REGARDING CHOICE AND CHEWING OF FOOD." "PATIENTS MUST BE CAUTIONED TO CHEW THEIR FOOD THOROUGHLY. PATIENTS WITH DENTURES MUST BE PARTICULARLY CAREFUL TO CUT THEIR FOOT INTO SMALL PIECES. FAILURE TO FOLLOW THESE PRECAUTIONS MAY RESULT IN VOMITING, STOMAL IRRITATION AND EDEMA, POSSIBLY EVEN OBSTRUCTION." DEVICE LABELING ADDRESSES THE REPORTED EVENTS OF NAUSEA AND VOMITING AS FOLLOWS: "NAUSEA AND VOMITING MAY OCCUR, PARTICULARLY IN THE FIRST FEW DAYS AFTER SURGERY AND WHEN THE PATIENT EATS MORE THAN RECOMMENDED. NAUSEA AND VOMITING MAY ALSO BE SYMPTOMS OF STOMA OBSTRUCTION OR A BAND/STOMACH SLIPPAGE."

    Description of Event or Problem · 1

    REPORTED EVENTS OF BAND SLIPPAGE, "OBSTRUCTED PROXIMAL STOMACH", NAUSEA, AND VOMITING FROM JOURNAL ARTICLE: "COMPLICATIONS OF LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING: OUR LOCAL EXPERIENCE", JOURNAL OF MEDICAL IMAGING AND RADIATION ONCOLOGY 56 (2012) 432-441.

    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 34 YR Required Intervention