BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 2960519 · Received February 7, 2013

    Report

    Report Number
    MW5028935
    Event Type
    Injury
    Date Received
    February 7, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 7, 2013
    Manufacturer
    UNK
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT HAD BILATERAL SILICONE IMPLANTS PLACED IN (B)(6) IN THE 1970S FOR AUGMENTATION. SHE HAD ISSUES WITH SILICONE LEAK IN THE 1990S WITH REMOVAL OF BILATERAL IMPLANTS. SHE HAD REMOVAL OF FIBROTIC AND FIRM TISSUE AND CAPSULE ON THE LEFT IN 2008. SHE PRESENTED WITH A NEW PALPABLE MASS IN THE LEFT BREAST PARENCHYMA (B)(6) 2013. WE PERFORMED A CORE BIOPSY OF THE PALPABLE MASS WHICH WAS HYPOECHOIC AND CONCERNING ON BEDSIDE ULTRASOUND. BIOPSY RESULTS SHOW ANAPLASTIC LARGE CELL LYMPHOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51436 UNKNOWN SILICONE BREAST IMPLANT FTR UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening