BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP BAND

    MDR report key: 1671951 · Received April 20, 2010

    Report

    Report Number
    1671951
    Event Type
    Malfunction
    Date Received
    April 20, 2010
    Date of Event
    April 1, 2010
    Report Date
    April 20, 2010
    Manufacturer
    ALLERGAN, INC.
    Product Code
    LTI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US

    Narratives

    Description of Event or Problem · 1

    AN ALLERGAN STANDARD LAP BAND WAS INSERTED BY THE SURGEON. WHEN REMOVING THE "TAIL" OF THE BAND THROUGH THE PORT, THE TAB SHEARED OFF AND BECAME FREE FROM THE BAND. THE PIECE OF THE BROKEN TAIL WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT AND REMOVED. OF NOTE: THIS TAB IS USED FOR GRASPING AND SHOULD BE ABLE TO HANDLE BEING GRIPPED BY GRASPERS. IN THIS CASE, WHILE IT WAS BEING GRASPED IT DID CLEANLY BREAK ACROSS THE TAB. THERE WAS NO INJURY TO PATIENT, BUT HAD THE BREAKAGE NOT BEEN NOTED, THE SHARP BROKEN PIECE COULD HAVE POTENTIALLY BEEN RETAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP BAND IMPLANT, INTRAGASTRIC, BANDING SYSTEM, ADJUSTABLE LTI ALLERGAN, INC. B-2240 *

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR