BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLERGAN NATRELLE

    MDR report key: 2232333 · Received August 25, 2011

    Report

    Report Number
    MW5021944
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    May 1, 2010
    Report Date
    August 25, 2011
    Manufacturer
    ALLERGAN
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    STARTED IN (B)(6) 2010 RECENTLY DIAGNOSED WITH SLE PLUS MIXED CONNECTIVE TISSUE DISORDER. JUST DISCHARGED FROM TWO-WEEK STAY IN HOSPITAL DUE TO COMPLICATIONS, INCLUDING PAIN, METHOTREXATE TOXICITY, BRAIN INFLAMMATION, RED BLOOD CELLS IN URINE PLUS CRYSTALS, RASH, ETC. DATES OF USE: (B)(6) 2008 - (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLERGAN NATRELLE SILICONE BREAST IMPLANTS FTR ALLERGAN 2008

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| L| O| R| S