BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM

    MDR report key: 1031303 · Received April 17, 2008

    Report

    Report Number
    2024601-2008-00184
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    December 24, 2007
    Report Date
    March 19, 2008
    Manufacturer
    BIOENTERICS CORP.
    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. VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER II. ANALYSIS OF THE DEVICE NOTED BREAKAGE OF THE PORT TUBING LOCATED NEAR THE STAINLESS STEEL CONNECTOR (THIS IS THE PORTION OF TUBING LOCATED BETWEEN THE STAINLESS STEEL CONNECTOR AND THE PORT, NOT BETWEEN THE STAINLESS STEEL CONNECTOR AND THE BAND). THE BREAKAGE OF THE PORT TUBING MAY BE WEAR RELATED AS THERE IS NO CLEAR EVIDENCE OF SURGICAL DAMAGE. THIS BREAKAGE MAY HAVE BEEN THE CAUSE OF THE LEAKAGE. ANOTHER BREAKAGE WAS NOTED IN THE BAND RING WHICH APPEARS TO HAVE BEEN CAUSED BY A SHARP INSTRUMENT. THIS BREAKAGE MAY HAVE BEEN MADE TO FACILITATE REMOVAL OF THE DEVICE, AND MAY NOT BE CAUSED OF THE LEAKAGE. 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

    REPORTED AS, THE PT WAS HAVING TROUBLE LOSING WEIGHT AND COULDN'T KEEP FLUID IN THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM DEVICE FOR TREATMENT OF MORBID OBESITY LTI BIOENTERICS CORP. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1