BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 1895310 · Received November 2, 2010

    Report

    Report Number
    2024601-2010-00870
    Event Type
    Injury
    Date Received
    November 2, 2010
    Date of Event
    September 20, 2010
    Report Date
    October 8, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. (B)(4). VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER II. ALLERGAN HAS RECEIVED THE PRODUCT HOWEVER THE ANALYSIS HAS NOT BEEN COMPLETED AT THIS TIME. 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." DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF DYSPHAGIA AS FOLLOWS: "ULCERATION, GASTRITIS, GASTROESOPHAGEAL REFLUX, HEARTBURN, GAS BLOAT, DYSPHAGIA, DEHYDRATION, CONSTIPATION AND WEIGHT REGAIN HAVE BEEN REPORTED AFTER GASTRIC RESTRICTION PROCEDURES."

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED REMOVAL OF A LAP-BAND BECAUSE OF BAND SLIPPAGE. THE DOCTOR PERFORMED AN UPPER GASTROINTESTINAL TEST AFTER THE PATIENT COMPLAINED OF REFLUX AND FOUND THAT THE LAP-BAND HAD SLIPPED. THE DEVICE WAS REMOVED BUT NOT REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA 1673507

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention