BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE BREAST IMPLANT

    MDR report key: 13868 · Received June 8, 1994

    Report

    Report Number
    MW1002401
    Event Type
    Malfunction
    Date Received
    June 8, 1994
    Date of Event
    April 12, 1990
    Report Date
    May 25, 1994
    Manufacturer
    UNKNOWN
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR HAD A SILICONE BREAST IMPLANT INSERTED IN 1975. SHE STATES THE PHYSICIAN AND HOSP CLAIM THEY HAVE NO RECORDS AND SHE DOES NOT KNOW THE MFR. THE IMPLANT WAS NOT RUPTURED, BUT IT WAS ENCAPSULATED AND VERY HARD TO THE TOUCH. ON 4/12/90, SHE HAD SURGICAL REMOVAL, SCRAPING, AND REPLACEMENT WITH ANOTHER SET OF IMPLANTS. OTHER PROBLEMS SHE BELIEVES TO BE RELATED TO SILICONE ARE: 1) OSTEOARTHRITIS WHICH IS CONSIDERED PREMATURE FOR HER AGE AND NOT IN HER HISTORY. 2) CHRONIC EYE PROBLEMS OF DRYNESS AND ACHING WHICH ARE LIKE AN ALLERGY. ALSO, IN 1993 SHE HAD NUMEROUS FLOATERS AND DIMINISHED VISION. THERE IS NO FAMILY HISTORY. 3) BASAL CELL CARCINOMA IN HAIRLINE FROM 7/93 TO PRESENT WHICH DOES NOT HEAL. SHE STATES THE DERMATOLOGIST SAID HE "NEVER SAW ANYTHING LIKE THIS." SHE STATES IT NOW SEEMS TO BE HEALING. SHE IS VERY CONCERNED. (SAME RPTR REFERRED TO IN 1002402.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE BREAST IMPLANT Implant SILICONE BREAST IMPLANT FTR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other