BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM VG

    MDR report key: 1834478 · Received September 10, 2010

    Report

    Report Number
    2024601-2010-00750
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    November 4, 2009
    Report Date
    July 26, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDWATCH SENT TO FDA ON: 10/08/2010. ANALYSIS SHOWED THAT THE BAND TUBING HAD A SHARP OPENING AND WAS IBLROIKIE~NI WITH STRIATIONS CONSISTENT WITH A SURGICAL END CUT TO REMOVE THE DEVICE. THE DAMAGED PORT SEPTUM HAD EVIDENCE OF MISSING MATERIAL. THE BUCKLE WAS BROKEN WITH STRIATIONS CONSISTENT WITH A SURGICAL END CUT TO REMOVE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120363 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM VG LTI ALLERGAN 1373301

    Patients

    Seq Age Sex Outcome Treatment
    1 Male