BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75CM

    MDR report key: 558109 · Received December 3, 2004

    Report

    Report Number
    2024601-2004-00700
    Event Type
    Injury
    Date Received
    December 3, 2004
    Date of Event
    October 13, 2004
    Report Date
    November 5, 2004
    Manufacturer
    BIOENTERICS CORPORATION
    Product Code
    LTI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTED AS, "LOSS OF PRESSION IN SYSTEM. TURNED PORT. IMPOSSIBLE TO PUNCTURE."

    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 NO INFO Required Intervention