BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75CM

    MDR report key: 1032633 · Received April 21, 2008

    Report

    Report Number
    2024601-2008-00204
    Event Type
    Malfunction
    Date Received
    April 21, 2008
    Date of Event
    March 20, 2008
    Report Date
    March 28, 2008
    Manufacturer
    BIOENTERICS CORPORATION
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER I. VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER I. 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

    REPORTED AS "DISCONNECTION OF THE CHAMBER BY RUPTURE OF THE TUBULE LINKING THE CHAMBER TO THE LAPBAND." (LEAK)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75CM DEVICE FOR TREATMENT OF MORBID OBESITY LTI BIOENTERICS CORPORATION NA S00LB115

    Patients

    Seq Age Sex Outcome Treatment
    1