BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM

    MDR report key: 394477 · Received May 15, 2002

    Report

    Report Number
    2028368-2002-00255
    Event Type
    Injury
    Date Received
    May 15, 2002
    Date of Event
    December 1, 2001
    Report Date
    April 16, 2002
    Manufacturer
    BIOENTERICS CORPORATION
    Product Code
    LTI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    "PT HAD REFLUX THROUGHOUT THE DURATION OF THE IMPLANTATION. THE PT HAD BEEN TESTED FOR REFLUX PRIOR TO IMPLANTATION AND SHOWED NO SIGNS OF REFLUX. THE PT COULD NOT TOLERATE THE LAP-BAND SYSTEM AND IN 12/2001 THE DR PARTIALLY DEFLATED THE BAND TO SEE IF THIS WOULD HELP RELIEVE THE REFLUX SYMPTOMS. PT DID NOT SHOW UP FOR SCHEDULED APPOINTMENT IN JANUARY. PT VOMITTED FOR TWO WEEKS PRIOR TO SEEING THE DR IN 03/2002. AT 03/2002 VISIT, A BARIUM SWALLOW WAS PERFORMED BY THE DR AND AN ENLARGED ESOPHAGUS WAS DISCOVERED. AT THAT TIME THE PT DECIDED TO HAVE THE BAND REMOVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM DEVICE FOR TREATMENT OF MORBID OBESITY LTI BIOENTERICS CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention