BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE BREAST IMPLANT

    MDR report key: 19728967 · Received July 11, 2024

    Report

    Report Number
    MW5157226
    Event Type
    Injury
    Date Received
    July 11, 2024
    Date of Event
    January 3, 2024
    Report Date
    July 10, 2024
    Manufacturer
    DOW CORNING / MENTOR WORLDWIDE LLC.
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    DOW CORNING BREAST IMPLANTS DOUBLE RUPTURE. SO FAR LARGE NECK MASS LARGE B CELL LYMPHOMA, BREAST IMPLANTS TO BE REMOVED (B)(6) 2024 AT MD (B)(6) CYTOLOGY TO FOLLOW. SILICONE, MASSES IN SPLEEN, RIGHT GROIN, AND TOTAL SPINE COVERED IN SOMETHING, POSSIBLE SILICON RELATED. VERY ILL. IN PROCESS SOON TO HAVE SURGERY AND CHEMO. MD (B)(6) HAS MORE DETAILS. STAGE 2B RIGHT NOW. REF REPORT: MW5157225.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2348004 SILICONE BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR DOW CORNING / MENTOR WORLDWIDE LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Life Threatening| H LEVEROXTHINE