BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILTEX SALINE-FILLED MAMMARY PROSTHESIS

    MDR report key: 2841310 · Received August 2, 2012

    Report

    Report Number
    1645337-2012-00123
    Event Type
    Injury
    Date Received
    August 2, 2012
    Report Date
    August 1, 2012
    Manufacturer
    MENTOR TEXAS, INC.
    Product Code
    FWM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    (B)(4). PER REPORT, PATIENT WAS "IMPLANTED WITH MENTOR TEXTURED SALINE BREAST IMPLANTS IN 1997. DIAGNOSED WITH SCLERODERMA SYSTEMIC LIMITED IN 2012." THERE WAS NO OTHER DEVICE OR PHYSICIAN INFORMATION WAS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILTEX SALINE-FILLED MAMMARY PROSTHESIS MAMMARY PROSTHESIS FWM MENTOR TEXAS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other