BEUDAMED
    FDA Adverse Event Summary report: N

    HEYER-SCHULTE BREAST IMPLANT, 165 CC

    MDR report key: 13407 · Received May 19, 1994

    Report

    Report Number
    MW1002115
    Date Received
    May 19, 1994
    Date of Event
    October 2, 1975
    Report Date
    April 29, 1994
    Manufacturer
    V. MUELLER DIV. BAXTER HEALTHCARE CORP.
    Product Code
    FTR
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR HAD A BILATERAL SUBCUTANEOUS MASTECTOMY WITH RECONSTRUCTION USING IMPLANTS. PROCEDURE WAS RECOMMENDED TO ELIMINATE FURTHER FORMATION OF CYSTS AND FUTURE BIOPSIES. RIGHT IMPLANT REPLACED WITH THIS CO'S IMPLANT AFTER ONSET OF EXTREME IRRITATION AND DRAINAGE. BEGINNING ABOUT 1974 CONTINUING TO DATE ARE THE FOLLOWING SYMPTOMS: JOINT PAIN, SWELLING OF ANKLES, SHOULDERS, ARMS, FINGERS, WRISTS AND KNEES, ENLARGED LYMPH GLANDS UNDER ARM, NIGHT SWEATING, VERY EXTREME FATIGUE, BURNING NUMBNESS OF HANDS AND FEET, NEURITIS DIAGNOSED IN 1979 AND NON-HODGKINS LYMPHOMA DIAGNOSED BY BIOPSY IN 1981. (SAME RPTR REFERRED TO IN 1002114 AND 1002116.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEYER-SCHULTE BREAST IMPLANT, 165 CC Implant FTR V. MUELLER DIV. BAXTER HEALTHCARE CORP. 3255, 3552

    Patients

    Seq Age Sex Outcome Treatment
    1 *