BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM

    MDR report key: 1213989 · Received October 27, 2008

    Report

    Report Number
    2024601-2008-00820
    Event Type
    Injury
    Date Received
    October 27, 2008
    Date of Event
    July 18, 2007
    Report Date
    July 18, 2007
    Manufacturer
    COSTA RICA
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER TYPE II. THE PRODUCT ASSOCIATED WITH THIS REPORT WILL NOT BE RETURNED. BASED UPON THE SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. BAND SLIPPAGE, REFLUX AND INADEQUATE WEIGHT LOSS ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS, AND ANALYSIS OF DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. DEVICE LABELING ADDRESSES THE REPORTED EVENTS OF BAND SLIPPAGE AND REFLUX 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 REPOSITIONING AND/OR REMOVAL.

    Description of Event or Problem · 1

    REPORTED BY THE PATIENT AS HAVING BAND SLIPPAGE WITH NO REVISION SURGERY SCHEDULED. FOLLOW UP WITH THE PATIENT REVEALS: "I HAD A BAND SLIPPAGE WITH REFLUX AND MY BAND REPLACED TO AN APS SIZE BAND."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM DEVICE FOR TREATMENT OF MORBID OBESITY LTI COSTA RICA N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention