BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLERGAN

    MDR report key: 1800917 · Received August 9, 2010

    Report

    Report Number
    MW5017059
    Event Type
    Injury
    Date Received
    August 9, 2010
    Date of Event
    July 26, 2010
    Report Date
    August 9, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD IMPLANT IN (B)(6) 2010. PT TAKEN TO THE OPERATING ROOM ON ABOVE DATE TO REMOVE DEFLATED TISSUE EXPANDER. UNK AS TO WHAT CAUSED THE DEFLATION TO OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLERGAN TISSUE EXPANDER, 400CC LCJ ALLERGAN 12918769

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Disability