BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NO RECORDS

    MDR report key: 165586 · Received April 21, 1998

    Report

    Report Number
    MW1013669
    Event Type
    Injury
    Date Received
    April 21, 1998
    Report Date
    April 14, 1998
    Manufacturer
    BAXTER HEALTHCARE CORP. HEYER SCHULTE
    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

    A 44 YR OLD WHITE FEMALE G2P2, STATUS POST BILATERAL SUBGLANDULAR INFRAMAMMARY GELS (NO RECORDS ON SIZE/TYPE STATES BAXTER) IN 1975, PLACED FOR AUGMENTATION. DENIES CHANGE IN SIZE, BUT SOFTER. POSITIVE HISTORY OF TRAUMA. MINIMAL LOCAL DISCOMFORT. ARTHRALGIAS, MYALGIAS, (POSITIVE MORNING STIFFNESS), SPASMS, PARESTHESIAS, FATIGUE, SWOLLEN GLANDS, HOT FLASHES, DIZZINESS, SINUS PROBLEMS, RASHES, SENSITIVITY TO COLD/CHEMICALS, POSITIVE RAYNAUD'S, SHORTNESS OF BREATH, CHOKING SENSATION, WEIGHT GAIN. MENSTRUAL/GENITOURINARY IRREGULARITIES, AND EASY BRUISING. RIGHT RUPTURED BREAST IMPLANT AND BILATERAL CALCIFIED CONTRACTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NO RECORDS Implant SILICONE GEL IMPLANT FTR BAXTER HEALTHCARE CORP. HEYER SCHULTE * *

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Congenital Anomaly| O