BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLERGAN LAP BAND

    MDR report key: 1595418 · Received January 14, 2010

    Report

    Report Number
    1595418
    Event Type
    Malfunction
    Date Received
    January 14, 2010
    Date of Event
    December 17, 2009
    Report Date
    January 14, 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

    OR STAFF REPORTS AN ALLERGAN LAP BAND SYSTEM BROKE APART ON STERILE TABLE PRIOR TO DELIVERY TO PROCEDURAL FIELD. DEVICE REMOVED FROM FIELD, NEW DEVICE OBTAINED WITH NO FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLERGAN LAP BAND STANDARD AP WITH ACCESS PORT I LTI ALLERGAN, INC. B-2240 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *