BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2010632 · Received March 1, 2011

    Report

    Report Number
    2024601-2011-00148
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    May 17, 2010
    Report Date
    February 1, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. (B)(4). THE PRODUCT ASSOCIATED WITH THIS REPORT WILL NOT BE RETURNED. BASED UPON THE INFORMATION THAT ALLERGAN'S AP BANDING DEVICE WAS USED IN THIS STUDY THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. FOLD IN TUBING IS A SURGICAL/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 FOLD IN TUBING AS FOLLOWS: "FAILURE TO CREATE A STABLE, SMOOTH PATH FOR THE ACCESS PORT TUBING, WITHOUT SHARP TURNS OR BENDS, CAN RESULT IN TUBING BREAKS AND LEAKAGE. IN ORDER TO AVOID INCORRECT PLACEMENT, THE PORT SHOULD BE PLACED LATERAL TO THE TROCAR OPENING. A POCKET MUST BE CREATED FOR THE PORT SO THAT IT IS PLACED FAR ENOUGH FROM THE TROCAR PATH TO AVOID ABRUPT KINKING OF THE TUBING."

    Description of Event or Problem · 1

    REPORTED EVENT OF: "TUBE KINK" FROM JOURNAL ARTICLE, "NEW ADJUSTABLE GASTRIC BANDS AVAILABLE IN THE UNITED STATED: A COMPARATIVE STUDY", SURGERY FOR OBESITY AND RELATED DISEASES 7 (2011) 74-81.

    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 NI Required Intervention