BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 157822 · Received March 18, 1998

    Report

    Report Number
    MW1013237
    Event Type
    Injury
    Date Received
    March 18, 1998
    Report Date
    May 30, 1995
    Manufacturer
    BAXTER HEALTHCARE COPR.
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT IS A 37-YR-OLD WHITE FEMALE, G2P2, STATUS POST IMPLANTATION OF SUBMUSCULAR INFRAMAMMARY 300 CC H/S GELS IN 89. LOCAL AND SYSTEMIC PROBLEMS PT HAS ARE PARESTHESIAS, FATIGUE, AXILLARY ADENOPATHY, HEADACHES, MEMORY LOSS, SICCA, HAIR LOSS, RASHES, SENSITIVITY TO SUN, MITRAL VALVE PROLAPSE, INCREASED CHOLESTEROL, GI/GU PROBLEMS, HEALTHY EXCEPT FOR HEPATITIS IN 87. PT IS LIGHT SMOKER. MRI 5/94 SHOWS BILATERAL RUPTURE. ON 3/7/95, BILATERAL CAPSULOTOMIES, REMOVAL OF RUPTURED GEL IMPLANTS, MARKED CLOUDY, MODERATE YELLOW CAPSULES WITH GRANULOMATOSIS WITH HISTIOCYTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * Implant SILICONE GEL BREAST IMPLANTS FTR BAXTER HEALTHCARE COPR. 350-7300 205247

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other| S