BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75CM

    MDR report key: 387348 · Received April 4, 2002

    Report

    Report Number
    2028368-2002-00185
    Event Type
    Malfunction
    Date Received
    April 4, 2002
    Date of Event
    February 28, 2002
    Report Date
    March 11, 2002
    Manufacturer
    BIOENTERICS CORPORATION
    Product Code
    LTI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BROKEN ACCESS PORT. A NEW PORT HAD TO BE IMPLANTED (FURTHER OPERATION FOR PT). F/U FINDINGS: TUBING LEAK AT OR NEAR THE CONNECTOR.

    Description of Event or Problem · 1

    BROKEN ACCESS PORT. A NEW PORT HAD TO BE IMPLANTED (FURTHER OPERATION FOR PT).

    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 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other