BEUDAMED
    FDA Adverse Event Other Summary report: N

    SILICONE GEL BREAST IMPLANT

    MDR report key: 251753 · Received November 29, 1999

    Report

    Report Number
    MW1017643
    Event Type
    Other
    Date Received
    November 29, 1999
    Report Date
    November 16, 1999
    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 RUPTURED IMPLANT AND BILATERAL REMOVAL. A 55 YR-OLD WHITE GRAVIDA 3 PARA 3 FEMALE STATUS POST BILATERAL SUBGLANDULAR INFRAMAMMARY GELS (300CC) IMPLANTED IN 1978 FOR AUGMENTATION. PT COMPLAINS OF INCREASED FIRMNESS AND PAIN TIMES ONE YR. NO HISTORY OF TRAUMA OR DECREASED SIZE. SHE HAS NO SYSTEMIC SYMPTOMS BUT HAS GAINED WEIGHT IN INTERVENING YEARS WITH INCREASED CHOLESTEROL. PT IS OTHERWISE HEALTHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE GEL BREAST IMPLANT Implant 200CC FTR DOW CORNING CORP. UNK H010658

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other