BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE GEL BREAST IMPLANT

    MDR report key: 165603 · Received April 24, 1998

    Report

    Report Number
    MW1013672
    Event Type
    Injury
    Date Received
    April 24, 1998
    Report Date
    April 7, 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 51 YR OLD WHITE FEMALE, STATUS POST BILATERAL SUBGLANDULAR INFRAMAMMARY. 265CC GELS HEYER SCHULTE, 06-04-76 PLACED FOR AUGMENTATION. THESE WERE FIRM EARLY. SHE DENIES A DECREASE IN SIZE BUT REPORTS HISTORY OF LEFT SELF CLOSED CAPSULOTOMIES, ARTHRALGIAS (MORNING STIFFNESS)/MYALGIAS, PARESTHESIAS/DYESTHESIAS, SPASMS, FATIGUE, SLEEP DISTURBANCES, ADENOPATHY, HOT FLASHES/CHILLS, HEADACHES, TEMPOROMANDIBULAR JOINT DISEASE, VISUAL CHANGES, DIZZY SPELLS, MEMORY LOSS, SICCA, RASHES, SENSITIVITY TO SUN, SHORTNESS OF BREATH/COUGH, CHOKING SENSATION, WEIGHT GAIN, AND GASTROINTESTINAL PROBLEMS, TINNITUS AND EASY BRUISING. BILATERAL RUPTURED IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE GEL BREAST IMPLANT Implant 265 CC FTR BAXTER HEALTHCARE CORP. HEYER SCHULTE 200 OVAL *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other| S