BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 156359 · Received March 7, 1998

    Report

    Report Number
    MW1013157
    Event Type
    Injury
    Date Received
    March 7, 1998
    Report Date
    February 17, 1995
    Manufacturer
    DOW CORNING CORP.
    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

    LEFT RUPTURE IMPLANT WITH INCIPIENT RUPTURE. A 59 YR OLD BLACK G3P3 FEMALE STATUS POST RIGHT MODIFIED RADICAL MASTECTOMY FOR STAGE I BREAST CANCER APRIL 1978. PRIOR HISTORY OF FIBROCYSTIC DISEASE BIOPSIES, FAMILY HISTORY POSITIVE, PATERNAL AUNT WITH PREMENOPAUSAL QUESTIONABLE LATERAL BREAST CANCER. MAY 1978 SHE HAD LEFT SUBCUTANEOUS "MANTX". JUNE 11, 1979 SHE HAD BILATERAL 235 CC SILASTIC IMPLANT TO RECONSTRUCT WITH RIGHT SUBCUTANEOUS LEFT UNDER MUSCLE. SHE HAD A SCAR REVISION JULY 28, 1980. JANUARY 24, 1983 PLUS RIGHT "NA" RECONSTRUCTION. JANUARY 6, 1984 COMPLAINED OF DECREASED SIZE TIMES 5 YRS. NO HISTORY OR TRAUMA. HAD LOCAL PAIN 7 YRS AFTER RECONSTRUCTION, RIGHT GREATER THAN LEFT. MRI POSITIVE FOR BILATERAL RUPTURE. OCTOBER 20, 1993 EXAM POSITIVE FOR SMALL LEFT INDENTS, POOR AESTHETIC RESULT WITH KELOIDS SYMPTOMS. NOVEMBER 19, 1994 PARTIAL LEFT RUPTURE, LIQUID GEL, RIGHT MARKED BLEED. BILATERALLY MODERATE CLOUDY/YELLOW, MODERATE "CAPS WITH MODERATE HISTO." PT HAS SYSTEMIC COMPLAINTS OF ARTHRALGIAS, MYALGIAS, FATIGUE, SLEEP DISTURBANCES, NEUROCOGNITIVE PROBLEMS ETC.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other| S