BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 1614602 · Received February 3, 2010

    Report

    Report Number
    1614602
    Event Type
    Injury
    Date Received
    February 3, 2010
    Date of Event
    January 12, 2010
    Report Date
    February 3, 2010
    Manufacturer
    UNKNOWN (LAP BAND NOT ORIGINALLY PLACED AT OUR FACILITY
    Product Code
    LTI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT PRESENTED TO HOSPITAL ED WITH AN ACUTE ABDOMEN AND FREE INTRAPERITONEAL AIR NOTED ON X-RAYS. THE PATIENT WAS TAKEN URGENTLY TO SURGERY FOR EXPLORATORY LAP, WHICH REVEALED THAT THE CATHETER FROM A PREVIOUS LAP BAND SURGERY HAD TWISTED AROUND THE SIGMOID COLON MESENTERY, RESULTING IN A SIGMOID VOLVULUS AND COLON PERFORATION. TO RELIEVE THIS ISSUE, THE SURGEON CUT THE CATHETER LAP BAND AND REMOVED A PORTION OF IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * LAP BAND LTI UNKNOWN (LAP BAND NOT ORIGINALLY PLACED AT OUR FACILITY * *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization