BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM

    MDR report key: 690494 · Received March 15, 2006

    Report

    Report Number
    2024601-2006-00155
    Event Type
    Malfunction
    Date Received
    March 15, 2006
    Date of Event
    February 2, 2006
    Report Date
    February 16, 2006
    Manufacturer
    COSTA RICA
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED ON MEDWATCH FROM UF/DIST REPORT # 06-001-2006-02 FORWARDED FROM THE HOSPITAL. REPORT OF "PT C/O ABDOMINAL PAIN WITH HISTORY OF 2 YR OLD LAP-BAND WHICH HAD BEEN PLACED BY A DIFFERENT PHYSICIAN. THE PATIENT WAS SCHEDULED FOR AN UPPER GI SERIES WITH SMALL BOWEL FOLLOW THROUGH WHICH SHOWED THAT THE LINE CONNECTING THE GASTRIC BAND TO THE PORT WAS BROKEN AT BOTH ENDS. THE PT AND PHYSICIAN MADE THE DECISION TO HAVE THE WHOLE UNIT SURGICALLY REMOVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM DEVICE FOR TREATMENT OF MORBID OBESITY LIT COSTA RICA NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other