BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP STD WITH ACCESS PORT II

    MDR report key: 3911950 · Received June 30, 2014

    Report

    Report Number
    3911950
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    January 30, 2014
    Report Date
    June 25, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A LAPAROSCOPIC ADJUSTABLE GASTRIC BAND AND HIATAL HERNIA REPAIR DONE ON APPROXIMATELY 3 YEARS AGO. APPROXIMATELY 7 MONTHS AGO, PATIENT WAS SEEN BY SURGEON AND BAND FLUID WAS CHECK AND IT HAD GONE FROM 3.0CC TO 1.5CC AFTER SEVERAL FLUID ADDITIONS SO LAPAROSCOPIC PROCEDURE WAS SCHEDULED TO REPLACE THE MEDICAL DEVICE APPROXIMATELY TWO WEEKS LATER. SURGEON COULD NOT IDENTIFY SOURCE OF LEAK WITH DYE TEST BUT BAND WAS REPLACED GIVEN HE COULD NOT IDENTIFY SOURCE OF LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379143 LAP-BAND AP STD WITH ACCESS PORT II IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI ALLERGAN LAP-BAND AP STD WITH ACCESS PORT II *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R