BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL)

    MDR report key: 2800984 · Received October 18, 2012

    Report

    Report Number
    2024601-2012-01103
    Event Type
    Injury
    Date Received
    October 18, 2012
    Date of Event
    August 7, 2012
    Report Date
    September 21, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALLERGAN HAS RECEIVED THE PRODUCT; HOWEVER, THE DEVICE HAS NOT BEEN IDENTIFIED, NOR HAS THE ANALYSIS BEEN COMPLETED AT THIS TIME. BASED UPON THE 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 AND OBSTRUCTION ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. HEALTH PROFESSIONAL HAS DECLINED TO PROVIDE ADD'L INFO. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF BAND SLIPPAGE 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 RESOLVED BY BAND DEFLATION. MORE SERIOUS SLIPPAGE 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, "BAND EXPLANTED DUE TO BAND SLIPPAGE/GASTRIC OUTLET OBSTRUCTION SECONDARY TO GASTRIC PROLAPSED, FAILURE OF DEVICE."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention