BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2314779 · Received October 26, 2011

    Report

    Report Number
    2024601-2011-00854
    Event Type
    Injury
    Date Received
    October 26, 2011
    Date of Event
    September 28, 2010
    Report Date
    September 27, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER UNK. (B)(4). THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT YET BEEN RETURNED. THE CONNECTOR TYPE CANNOT BE IDENTIFIED NOR AN ASSUMPTION MADE AS TO THE TYPE OF CONNECTOR ASSOCIATED WITH THIS COMPLAINT BECAUSE NO SERIAL NUMBER OR IMPLANT DATE WAS GIVEN. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. DEVICE LABELING ADDRESSES THE EVENT OF LEAK AS FOLLOWS: "DEFLATION OF THE BAND MAY OCCUR DUE TO LEAKAGE FROM THE BAND, THE PORT OR THE CONNECTOR TUBING."

    Description of Event or Problem · 1

    REPORTED EVENTS OF "ABDOMINAL PAIN", A DISCONNECTED PORT, URINARY FREQUENCY, AND DYSURIA FROM JOURNAL ARTICLE: "AN UNUSUAL CAUSE OF DYSURIA", ANN R COLL SURG ENGL (2011) 93: E64-E66.

    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 36 YR Required Intervention