BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAMMARY IMPLANT

    MDR report key: 16373 · Received September 23, 1994

    Report

    Report Number
    MW1003498
    Event Type
    Injury
    Date Received
    September 23, 1994
    Date of Event
    July 10, 1980
    Report Date
    September 16, 1994
    Manufacturer
    DOW CORNING CORP.
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPRT HAD A MODIFIED RADICAL MASTECTOMY OF RIGHT BREAST FOR CANCER IN 2/76. ON 9/4/79 SHE HAD A SUBCUTANEOUS MASTECTOMY OF LEFT BREAST BECAUSE OF DIAGNOSIS OF POTENTIAL CANCER. ON 7/10/80 BILATERAL BREAST IMPLANTS. ON 5/27/81, SHE HAD CAPSULAR CONTRACTURE AND LEFT IMPLANT WAS REMOVED AND REPLACED WITH THIS IMPLANT. SHE HAD ADDITIONAL SCAR TISSUE AND BLOOD POCKETS THAT HAD TO BE REMOVED BILATERALLY. (ALSO SEE 1003497).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMMARY IMPLANT Implant MAMMARY IMPLANT FTR DOW CORNING CORP. RIGHT 180 CC RIGHT H089617

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Disability