BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2130579 · Received June 14, 2011

    Report

    Report Number
    2024601-2011-00499
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 23, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER UNKNOWN. MEDWATCH SENT TO FDA ON: (B)(4) 2011. THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS AS WELL AS TO INDICATE THE PRODUCT SERIAL NUMBER, THE DATE OF THE EVENT, AND THE IMPLANT AND EXPLANT DATES. THIS INFO HAS NOT YET BEEN RECEIVED BY ALLERGAN. THE CONNECTOR TYPE CANNOT BE IDENTIFIED NOR AN ASSUMPTION BE MADE AS TO THE TYPE OF CONNECTOR ASSOCIATED WITH THIS COMPLAINT BECAUSE NO SERIAL NUMBER OR IMPLANT DATE WAS GIVEN. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. BAND SLIPPAGE IS A SURGICAL AND PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF BAND SLIPPAGE AS FOLLOWS: "SLIPPAGE OF THE BAND CAN OCCUR. GASTROESOPHAGEAL 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."

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED AN ALLEGED BAND SLIPPAGE WITH A LAP-BAND DEVICE.

    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 46 YR Required Intervention LEVOXYL| LOSARTAN| METFORMIN| LUTERA| SIMVASTATIN