BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILTEX MAMMARY PROTHESIS

    MDR report key: 3981224 · Received July 24, 2014

    Report

    Report Number
    1645337-2014-00125
    Event Type
    Injury
    Date Received
    July 24, 2014
    Report Date
    July 24, 2014
    Manufacturer
    MENTOR TEXAS, INC.
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AUTOIMMUNE SYMPTOMS, RUPTURE AND BREAST PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435484 SILTEX MAMMARY PROTHESIS BREAST IMPLANT FTR MENTOR TEXAS, INC. 6002065

    Patients

    Seq Age Sex Outcome Treatment
    1 Other