BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM

    MDR report key: 2202572 · Received August 5, 2011

    Report

    Report Number
    2024601-2011-00620
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    February 23, 2011
    Report Date
    July 11, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER II. ALLERGAN HAS RECEIVED THE PRODUCT, HOWEVER, THE ANALYSIS HAS NOT BEEN COMPLETED AT THIS TIME. NO ADDITIONAL INFORMATION HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER OF THE DEVICE. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF LEAKAGE AS FOLLOWS: "DEFLATION OF THE BAND MAY OCCUR DUE TO LEAKAGE FROM THE BANK, THE PORT OR THE CONNECTOR TUBING."

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED, THE REMOVAL OF A LAP-BAND ACCESS PORT DUE TO ALLEGED LEAK. PER THE REPORTER, "THE TUBING HAD WORN THROUGH" WHICH CAUSED A LEAKAGE. THE ALLEGED LEAK WAS FIRST NOTICED WHEN "DURING BAND ADJUSTMENT PROCEDURE, FLUID WAS MISSING FROM BAND." "THIS WAS CONFIRMED WITH A (B)(6 )STUDY THAT SHOWED CONTRAST LEAKING INTO THE ABDOMEN WHEN INJECTING INTO THE LAP BAND SYSTEM." THE PORT WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR CLARITIN| SANCTURA| IBUPROFEN| CLONAZEPAM| ASPIRIN| LEXAPRO| MELATONIN