BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEYER-SCHULTE MAMMARY PROSTHESIS

    MDR report key: 27563 · Received October 30, 1995

    Report

    Report Number
    MW1007499
    Event Type
    Other
    Date Received
    October 30, 1995
    Date of Event
    January 1, 1986
    Manufacturer
    BAXTER V. MUELLER
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    53-YR-OLD WHITE FEMALE WHO IN 1974 HAD MAMMOPEXY AND IMPLANTS (SILICONE). AROUND 1976 SHE STARTED HAVING PROBLEMS WITH PAIN IN RT BREAST. IN THE 1980'S SHE STARTED NOTICING HARDENING OF THE RT BREAST. NO CAPSULOTOMY. MAMMOGRAMS SHOWED OPACITIES AND LEAKAGE, BETWEEN 1991 AND 1993 SHE NOTICED A KNOT UNDER HER RT ARM WHICH INCREASED IN SIZE. AROUND 1988 SHE STARTED HAVING PAIN IN HER RT WRIST AND HAND, NOTING PAIN AND DECREASED STRENGTH. AROUND 1990-91 SHE NOTED TINGLING AND RAYNAUD CHANGES IN HER RT HAND, AROUND 1987-88 SHE DEVELOPED (RT) LOWER EXTREMITY PAIN. THE PAIN WAS SO INTENSE THAT SHE HAD TWO NERVE BLOCKS. SHE HAD PREVIOUSLY BEEN DRAGGING HER LEG; NOW SHE WALKS NORMALLY UNLESS SHE WORKS A 12-14 HR SHIFT. SHE HAD BEEN WORKING IN A FACTORY UNTIL 1986 WHEN SHE HAD TO RETIRE BECAUSE SHE WAS PHYSICALLY INCAPABLE OF LIFTING. SHE HAS BEEN DIAGNOSED WITH: RAYNAUD'S (GROUP I), MYALIGAS (GROUP II), ARTHRALGIAS (GROUP III), SLEEP DISTURBANCE (GROUP III), PARESTHESIAS (GROUP III), CHEST WALL/BREAST PAIN (GROUP III), LYMPHADENAPATHY (GROUP II). (*)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEYER-SCHULTE MAMMARY PROSTHESIS HEYER-SCHULTE MAMMARY PROSTHESIS FTR BAXTER V. MUELLER

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other