BEUDAMED
    FDA Adverse Event Summary report: N

    AMERICAN HEYER SCHULTE MAMMARY PROSTHESIS

    MDR report key: 27567 · Received October 30, 1995

    Report

    Report Number
    MW1007502
    Date Received
    October 30, 1995
    Manufacturer
    BAXTER V. MUELLER
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT'S INDEX FINGER SWELLS. SHE HAS NECK, BACK, HIP, ARM, LEG AND FOOT PAIN. BALANCE DISTURBANCE, BLADDER TROUBLE, VAGINAL DISCHARGE, EASY BRUISING, CHRONIC FATIGUE, HEADACHES, DIFFICULTY FIGHTING INFECTIONS, RASHES ON BOTH ARMS IN THE WINTER, TINGLING IN FINGERS AND TOES, MEMORY LOSS, DEPRESSIONS AND CHEST PAIN WHEN SHE GETS TIRED. SHE HAS BEEN DIAGNOSED WITH: MYALGIAS (GROUP II), ARTHRALGIAS (GROUP III), CHRONIC FATIGUE (GROUP III), IMMUNE MEDIATED SKIN RASH (GROUP II), NIGHT SWEATS (GROUP III), AND PARESTHESIAS (GROUP III). (*)

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *