BEUDAMED
    FDA Adverse Event Summary report: N

    HEYER-SCHULTE MAMMARY PROSTHESIS

    MDR report key: 13306 · Received May 18, 1994

    Report

    Report Number
    MW1002044
    Date Received
    May 18, 1994
    Date of Event
    May 9, 1980
    Report Date
    May 5, 1994
    Manufacturer
    V. MUELLER DIV. BAXTER HEALTHCARE CORP.
    Product Code
    FTR
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    PT COMPLAINS OF RUPTURED IMPLANTS, MUSCLE ACHES AND PAINS, BREAST HARDNESS, ITCHING, ENLARGED GLANDS, FATIGUE, SWELLING OF HANDS AND FEET, RASHES, NERVE INFLAMMATION, BURNING PAIN IN CHEST, DRY EYES AND VAGINA, JOINT TENDERNESS, EASY BRUISING, NOSE AND MOUTH ULCERS, AND TINGLING IN LEGS AND ARMS. (SAME PT REFERRED TO IN 1002045.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEYER-SCHULTE MAMMARY PROSTHESIS Implant FTR V. MUELLER DIV. BAXTER HEALTHCARE CORP. 202878

    Patients

    Seq Age Sex Outcome Treatment
    1 *