BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM VG

    MDR report key: 1083083 · Received July 23, 2008

    Report

    Report Number
    2024601-2008-00387
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    June 17, 2008
    Report Date
    June 23, 2008
    Manufacturer
    COSTA RICA
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. MEDWATCH SENT TO FDA ON: 07/23/08. THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT YET BEEN RETURNED. BASED ON THE REPORTED MODEL (VG) OF THE LAP-BAND SYSTEM, THE CONNECTOR TYPE IS ASSUMPTION TO BE A TAPER II. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE NO ANALYSIS OR TESTING HAS BEEN DONE. FURTHER INFO FROM THE REPORTER REGARDING THE SERIAL NUMBER AND THE IMPLANT DATE HAS BEEN REQUESTED. 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: "CATHETER RUPTURE." (LEAK).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR