BEUDAMED
    FDA Adverse Event Summary report: N

    CRONIN SILASTIC IMPLANT

    MDR report key: 13406 · Received May 19, 1994

    Report

    Report Number
    MW1002114
    Date Received
    May 19, 1994
    Date of Event
    October 4, 1972
    Report Date
    April 29, 1994
    Manufacturer
    DOW CORNING CORP.
    Product Code
    FTR
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR HAD A BILATERAL SUBCUTANEOUS MASTECTOMY WITH RECONSTRUCTION USING THESE IMPLANTS. PROCEDURE WAS RECOMMENDED TO ELIMINATE FURTHER FORMATION OF CYSTS AND FUTURE BIOPSIES. RIGHT IMPLANT WAS LATER REPLACED AFTER ONSET OF EXTREME IRRITATION AND DRAINAGE. BEGINNING ABOUT 1974 CONTINUING TO DATE ARE THE FOLLOWING SYMPTOMS: JOINT PAIN, SWELLING OF ANKLES, SHOULDERS, ARMS, FINGERS, WRISTS AND KNEES, ENLARGED LYMPH GLANDS UNDER ARM, NIGHT SWEATING, VERY EXTREME FATIGUE, BURNING NUMBNESS OF HANDS AND FEET, NEURITIS DIAGNOSED IN 1979 AND NON-HODGKINS LYMPHOMA DIAGNOSED BY BIOPSY IN 1981. (SAME RPTR REFERRED TO IN 1002115 AND 1002116.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRONIN SILASTIC IMPLANT Implant FTR DOW CORNING CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 *