BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 1820025 · Received August 24, 2010

    Report

    Report Number
    2024601-2010-00621
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    July 2, 2010
    Report Date
    August 2, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. (B)(4). THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT YET BEEN RETURNED. BASED UPON THE SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. VISUAL EXAMINATION MAY CONFIRM OR DETERMINE ANOTHER CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. 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

    ALLERGAN SALES REPRESENTATIVE REPORTED ON BEHALF OF A HEALTH PROFESSIONAL REGARDING AN ALLEGED PORT SEPTUM LEAK AFTER THE PATIENT LOST 1.2CC OF SALINE FROM A PREVIOUS VISIT ABOUT TWO WEEKS PRIOR. AN X-RAY SHOWED NO ISSUES WITH THE DEVICE. THE DEVICE HAS NOT BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA 1803159

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR