BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 1924360 · Received December 7, 2010

    Report

    Report Number
    2024601-2010-00974
    Event Type
    Injury
    Date Received
    December 7, 2010
    Date of Event
    September 20, 2010
    Report Date
    November 9, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 REC'D THE PRODUCT; HOWEVER, THE ANALYSIS HAS NOT BEEN COMPLETED AT THIS TIME. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF POUCH DILATATION AS FOLLOWS: "FREQUENT, SEVERE VOMITING CAN RESULT IN POUCH DILATATION, STOMACH SLIPPAGE OR ESOPHAGEAL DILATATION. BAND SLIPPAGE AND/OR POUCH DILATATION CAN OCCUR."

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED A "PORT REMOVAL DUE TO POUCH DILATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA 1636931

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention