BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOW CORNING

    MDR report key: 970409 · Received December 22, 2007

    Report

    Report Number
    MW5004798
    Event Type
    Injury
    Date Received
    December 22, 2007
    Date of Event
    December 15, 2007
    Report Date
    December 22, 2007
    Manufacturer
    DOW CORNING
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SILICONE BREAST IMPLANTS FROM 1972, RUPTURES FOUND DURING A ROUTINE MAMMOGRAM. FURTHER CONFIRMED THROUGH AN MRI. SURGICAL INTERVENTION NEEDED FOR REMOVAL OF IMPLANTS AS WELL AS MIGRATED SILICONE IN OTHER PARTS OF BODY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening| O