BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM

    MDR report key: 2800973 · Received October 18, 2012

    Report

    Report Number
    2024601-2012-01124
    Event Type
    Injury
    Date Received
    October 18, 2012
    Date of Event
    August 27, 2012
    Report Date
    September 27, 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

    MEDWATCH SENT TO FDA ON: (B)(4) 2012. ALLERGAN HAS RECEIVED PRODUCT, HOWEVER, THE DEVICE HAS NOT BEEN IDENTIFIED NOR HAS THE ANALYSIS BEEN COMPLETED AT THIS TIME. BASED UPON THE MODEL NUMBER, SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. BAND SLIPPAGE IS A SURGICAL/PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. HEALTH PROFESSIONAL HAS DECLINED TO PROVIDE ADDITIONAL INFORMATION. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF BAND SLIPPAGE 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 SLIPPAGES MAY REQUIRE BAND REPOSITIONING AND/OR REMOVAL. IF THERE IS A 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, "EXPLANTED BAND/DUE TO BAND SLIPPAGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM LTI ALLERGAN NA 1167688

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention