BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP ADJUSTALE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 2802477 · Received October 18, 2012

    Report

    Report Number
    2024601-2012-01128
    Event Type
    Malfunction
    Date Received
    October 18, 2012
    Date of Event
    June 1, 2012
    Report Date
    September 27, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALLERGAN HAS RECEIVED THE PRODUCT, HOWEVER, THE DEVICE HAS NOT BEEN IDENTIFIED, NOR HAS THE ANALYSIS BEEN COMPLETED AT THIS TIME. BASED UPON THE MODEL NUMBER, SERIAL NUMBER, AND IMPLANT DATE PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. VISUAL EXAMINATION MAY CONFIRM OR DETERMINE ANOTHER CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. HEALTH PROFESSIONAL HAS DECLINED TO PROVIDE ADD¿L INFO. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF LEAKAGE 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

    HEALTH PROFESSIONAL REPORTED: ¿EXPLANTED BAND/DUE TO PORT LEAKAGE.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTALE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA 1470336

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR