BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM ACCESS PORT I

    MDR report key: 1191899 · Received September 30, 2008

    Report

    Report Number
    2024601-2008-00755
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Date of Event
    August 28, 2008
    Report Date
    September 4, 2008
    Manufacturer
    COSTA RICA
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER I. VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER I. ALLERGAN HAS RECEIVED THE PRODUCT, HOWEVER, THE ANALYSIS RESULTS ARE PENDING AT THIS TIME. 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

    REPORTED BY THE PT AS A PORT LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM ACCESS PORT I DEVICE FOR TREATMENT OF MORBID OBESITY LTI COSTA RICA NA 1158013

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR