BEUDAMED
    FDA Adverse Event Summary report: N

    HEYER SCHULTE BREAST IMPLANT

    MDR report key: 14641 · Received July 13, 1994

    Report

    Report Number
    MW1002791
    Date Received
    July 13, 1994
    Date of Event
    September 12, 1977
    Report Date
    June 26, 1994
    Manufacturer
    V. MUELLER DIV. BAXTER HEALTHCARE CORP.
    Product Code
    FTR
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IMPLANTS PLACED 9/12/77. PROBLEMS STARTED 11/78, WITH DISCOMFORT, REDNESS, PAIN, HEAT, ITCHING, AND HARDNESS IN RIGHT BREAST. SYMPTOMS CONTINUED OFF AND ON FOR 13 YRS. PENICILLIN USUALLY HELPED. DEVICES REMOVED (RIGHT CAPSULE ALSO) 4/23/91, AND REPLACED BY ANOTHER CO'S DEVICES. NEW IMPLANTS WERE PLACED UNDER MUSCLE THIS TIME. RPTR STILL HAS SOME ITCHINESS AND DISCOMFORT ON RIGHT SIDE AND HAS SEVERAL LUMPS IN RIGHT BREAST. ONE LUMP WAS BIOPSIED 5/5/92. RPTR IS VERY CONCERNED. (SAME RPTR AS 1002792.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEYER SCHULTE BREAST IMPLANT Implant BREAST IMPLANT FTR V. MUELLER DIV. BAXTER HEALTHCARE CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR