BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM VG

    MDR report key: 1915279 · Received November 2, 2010

    Report

    Report Number
    2024601-2010-00855
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Date of Event
    September 2, 2010
    Report Date
    October 6, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON: (B)(4) 2010. VISUAL EXAM 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. 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

    SURGEON REPORTED, "PT DIDN'T GET RESTRICTION OF THE BAND. DURING X-RAY, IT WAS NOTICED THAT THE TUBING WAS COMPLETELY BROKEN. THE PT WAS RE-OPERATED AND GOT A NEW BAND."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR