BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75CM

    MDR report key: 2945427 · Received February 1, 2013

    Report

    Report Number
    2024601-2013-00042
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 2013
    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

    (B)(4). THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT BEEN RETURNED AS THE DEVICE WAS NOT EXPLANTED. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS, IF IT IS EXPLANTED IN THE FUTURE. THE SURGERY WAS NOT OCCURRED, SO ALLERGAN HAS NOT RECEIVED THE DEVICE NOR PERFORMED ANALYSIS AT THIS TIME. BASED UPON THE SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER I. DEVICE LABELING ADDRESSES THE POSSIBLE OF LEAKAGE FROM THE BAND, THE PORT OR THE CONNECTOR TUBING."

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED A LAP-BAND TUBING LEAK FIRST NOTICED DURING AN INITIAL CONSULTATION VIA FLUOROSCOPY. THE DEVICE REMAINS IMPLANTED HOWEVER EXPLANT SURGERY IS CURRENTLY SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45037 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75CM LTI ALLERGAN NA S02LB132

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR NONE REPORTED.