BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1002170 · Received January 28, 2008

    Report

    Report Number
    1002170
    Event Type
    Malfunction
    Date Received
    January 28, 2008
    Date of Event
    January 23, 2008
    Report Date
    January 28, 2008
    Manufacturer
    ALLERGAN, INC.
    Product Code
    LCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AN ALLERGAN TISSUE EXPANDER WAS IMPLANTED. IT WAS REMOVED 6 MONTHS LATER AS IT WAS LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * TISSUE EXPANDER LCJ ALLERGAN, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR