BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLERGAN LAP BAND

    MDR report key: 1800920 · Received August 9, 2010

    Report

    Report Number
    MW5017061
    Event Type
    Malfunction
    Date Received
    August 9, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 9, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT PLACEMENT OF ALLERGAN LAP BAND. THE BAND CRACKED DURING THE PROCEDURE; ALL COMPONENTS REMOVED AND PROCEDURE TERMINATED. NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLERGAN LAP BAND LAP BAND AP STANDARD WITH ACCESS PORT LTI ALLERGAN REF B-2240

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR