BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATRELLE SILICONE FILLED BREAST IMPLANT

    MDR report key: 4251255 · Received November 5, 2014

    Report

    Report Number
    MW5039014
    Event Type
    Injury
    Date Received
    November 5, 2014
    Date of Event
    April 8, 2008
    Report Date
    November 5, 2014
    Manufacturer
    ALLERGEN, INC
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    NATRELLE SILICONE FILLED BREAST IMPLANTS LEAKED. I HAVE SINCE BEEN DIAGNOSED WITH SILICONE LYMPHADENOPATHY, LUPUS, AND HAVE HAD TO BE TESTED FOR UNK MASSES WHICH SO FAR HAVE TURNED OUT AS SILICONE FILLED LYMPH NODES...EVEN YEARS AFTER REMOVAL OF IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710430 NATRELLE SILICONE FILLED BREAST IMPLANT BREAST IMPLANT FTR ALLERGEN, INC REF 110-270
    710528 NATERELLE SILICONE FILLED BREAST IMPLANT BREAST IMPLANT FTR ALLERGEN, INC REF 110-270

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Disability