BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOW CORNING

    MDR report key: 1220681 · Received November 3, 2008

    Report

    Report Number
    MW5008854
    Event Type
    Injury
    Date Received
    November 3, 2008
    Report Date
    November 3, 2008
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BIL IMPLANTS 1980'S - RECENTLY INCREASED HARDNESS GREATER ON LEFT THAN RIGHT, INCREASED PAIN AND DISCOMFORT - ON MAMMOGRAM QUESTIONABLE RUPTURE. P.E. GRADE II CAPSULAR CONTRACTION. LEFT GREATER THAN RIGHT. LEFT ALSO SMALLER THAN RIGHT. IN 2008, BIL CAPSULECTOMY AND IMPLANT REMOVAL - IMPLANTS REMOVED INTACT - AUGMENTED WITH 400CC MENTOR MOD AND GEL IMPLANTS - BIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOW CORNING GEL IMPLANTS FTR UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention