BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 3012521 · Received March 15, 2013

    Report

    Report Number
    2024601-2013-00154
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 15, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. (B)(4). THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. THE DEVICE HAS NOT YET BEEN RECEIVED BY ALLERGAN. BASED UPON THE PARTIAL IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. BAND SLIPPAGE, OBSTRUCTION, AND VOMITING ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. NO ADDITIONAL INFORMATION HAS BEEN REPORTED TO ALLERGAN REGARDING THE ACTUAL IMPLANT DATE, SERIAL NUMBER OR MODEL NUMBER. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF BAND SLIPPAGE, VOMITING, AND OBSTRUCTION AS FOLLOWS: "SLIPPAGE OF THE BAND CAN OCCUR. GASTRO-ESOPHAGEAL REFLUX, NAUSEA AND/OR VOMITING WITH EARLY OR MINOR SLIPPAGE MAY BE IN SOME CASES SUCCESSFULLY RESOLVE BY BAND DEFLATION. MORE SERIOUS SLIPPAGES MAY REQUIRE BAND REPOSITIONING AND/OR REMOVAL. IF THERE IS TOTAL STOMA OUTLET OBSTRUCTION THAT DOES NOT RESPOND TO BAND DEFLATION, OR IF THERE IS ABDOMINAL PAIN, THEN IMMEDIATE RE-OPERATION TO REMOVE THE BAND IS INDICATED."

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED A LAP-BAND SYSTEM REMOVAL WITH NO INFORMATION. FOLLOW-UP INFORMATION: HEALTH PROFESSIONAL REPORTED LAP-BAND SYSTEM WAS EXPLANTED DUE TO "GASTRIC OUTLET OBSTRUCTION FROM GASTRIC SLIPPAGE." EVENT WAS FIRST NOTICED WHEN PATIENT COMPLAINED OF "DAILY VOMITING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110245 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention