BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75CM

    MDR report key: 3900302 · Received May 6, 2014

    Report

    Report Number
    2024601-2014-00276
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    November 26, 2013
    Report Date
    December 20, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER II. THE EXAMINATION ALSO DETERMINED THE BAND TO BE A 9.75CM LAP-BAND SYSTEM. ANALYSIS NOTED A THINNER SURFACE AND SMOOTH OPENINGS AT THE BAND TUBING, THE TUBING-COLLAR JUNCTION AND THE PORT TUBING AT THE STAINLESS STEEL CONNECTOR CONSISTENT WITH WEAR AND TEAR. ANALYSIS NOTED THAT THE BAND TUBING WAS BROKEN WITH STRIATIONS CONSISTENT WITH SURGICAL END CUT TO REMOVE THE DEVICE. NO ADD'L INFO HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER, THE EVENT DATE, IMPLANT DATE, IMPLANT SURGEON, DIAGNOSTIC TESTING, PATIENT DATA OR EVENT DETAILS.

    Description of Event or Problem · 1

    NO INFO GIVEN. INVESTIGATION IN PROGRESS. DEVICE ANALYSIS DETERMINED THAT THERE WERE MULTIPLE SMOOTH, WEAR RELATED OPENINGS ON THE DEVICE, WITH LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271534 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75CM LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR