BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM

    MDR report key: 2153476 · Received June 21, 2011

    Report

    Report Number
    2024601-2011-00505
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    March 24, 2011
    Report Date
    May 24, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. MEDWATCH SENT TO FDA ON: (B)(4) 2011. VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER II. ANALYSIS NOTED THE ACCESS PORT HAD NON-PENETRATING NICKS WITH STRIATIONS DESCRIBED AS SURGICAL TOOL SCRATCH-LIKE. THE BAND TUBING WAS BROKEN WITH STRIATIONS CONSISTENT WITH A SURGICAL END CUT TO REMOVE THE DEVICE. 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

    HEALTH PROFESSIONAL REPORTED PORT EXPLANT AND REPLACEMENT DUE TO ALLEGED "LEAK AND PROTRUDING OUTWARD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR