BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE MAMMARY IMPLANT

    MDR report key: 17587 · Received November 11, 1994

    Report

    Report Number
    MW1004002
    Event Type
    Injury
    Date Received
    November 11, 1994
    Date of Event
    April 13, 1981
    Report Date
    November 4, 1994
    Manufacturer
    UNKNOWN
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RUPTURE OF BREAST IMPLANT WITH SILICONE RELEASED INTO TISSUES, CLOSED ENCAPSULOTOMY. ARTHRITIS SYMPTOMS, BREAST CANCER, JOINT PROBLEMS, FROZEN SHOLDER AND FOOT NEUROMAS. ALSO SEE 1004003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE MAMMARY IMPLANT Implant BREAST IMPLANT FTR UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other| R