BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEL-FILLED MAMMARY IMPLANT

    MDR report key: 15181 · Received August 10, 1994

    Report

    Report Number
    MW1003068
    Event Type
    Injury
    Date Received
    August 10, 1994
    Date of Event
    September 24, 1976
    Report Date
    August 7, 1994
    Manufacturer
    DOW CORNING CORP.
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SHORTLY AFTER IMPLANT RPTR BEGAN HAVING RASHES AND NAILS DETERIORATED, WITHIN A FEW YEARS EYESIGHT BEGAN TO BLUR. FATIGUE SET IN. SHE WAS TIRED ALL THE TIME. LEGS HURT A LOT, MEMORY BEGAN TO GO BAD. LEGS, FEET AND HANDS SWELL. BEGAN HAVING HOT FLASHES IN HER 30'S AND IT WAS NOT MENOPAUSE. MANY MANY YEAST INFECTIONS, HEADACHES, BOWEL PROBLEMS, RASHES, CHEST PAIN, COULD NOT LIE ON STOMACH, NIPPLE NUMBNESS, LOWER BACK PAIN, FOOD ALLERGIES AND CHEMICAL SENSITIVITIES, NUMBNESS IN HANDS AND FEET, MUSCLES WEAK, COLD ALL THE TIME AND EYES WEAK. SYMPTOMS HAVE CONTINUED TO PROGRESS OVER TIME, AS OF THIS DATE AND HAVE NOT IMPROVED. THE SAME RPTR IS REFERRED TO IN 1003067.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEL-FILLED MAMMARY IMPLANT Implant SILICONE BREAST IMPLANT FTR DOW CORNING CORP. HH3615

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention| S