BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEL FILLED MAMMARY IMPLANT

    MDR report key: 43288 · Received October 16, 1996

    Report

    Report Number
    1816403-1996-00154
    Event Type
    Injury
    Date Received
    October 16, 1996
    Date of Event
    January 1, 1979
    Report Date
    September 17, 1996
    Manufacturer
    DOW CORNING CORP
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT ALLEGES RECEIVING BREAST IMPLANTS IN AUG, 1976 OF AN UNK MFR. PT ALSO ALLEGES THREE YEARS LATER (IE. 1979) SHE WAS SICK AND ONE DAY SHE WAS PARALYZED ON HER LEFT ARM AND LEFT SIDE. SHE HAS HAD PAIN FROM MORNING TO NIGHT AND HER DOCTOR COULD NOT FIND ANYTHING WRONG WITH HER. ON DEC. 13, 1994 SHE HAD REMOVAL AND REPLACEMENTS WITH DEVICES OF ANOTHER MFR AND UPON REMOVAL HER IMPLANTS WERE RUPTURED AND BROKEN. PT ALSO ALLEGES SHE IS A VERY "REDUSED" PERSON TODAY AND REPORTED HAVING "SICCA/SJOGREN", A HEART DISEASE, HER JOINTS ARE "GROWING", HER MEMORY IS GONE, HER HIPS AND LEGS "DON'T LIKE TO WALK MUCH", HER TEETH ARE FALLING OUT, SHE HAS INFECTIONS ALL OF THE TIME AND HER "IMMUNE SYSTEM IS FLAT BROKE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEL FILLED MAMMARY IMPLANT Implant MAMMARY IMPLANT, GEL-FILLED FTR DOW CORNING CORP NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other| R| S