BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE GEL BREAST IMPLANT

    MDR report key: 205461 · Received December 30, 1998

    Report

    Report Number
    MW1015395
    Event Type
    Injury
    Date Received
    December 30, 1998
    Report Date
    December 28, 1998
    Manufacturer
    UNK
    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

    A 38 YEAR OLD WHITE GRAVIDA 2, PARA 2 FEMALE; STATUS POST BILATERAL SUBGLANDULAR INFRAMAMMARY BILUMEN IMPLANTS (? SIZE/TYPE/MFR - NO RECORDS) IN 05-18-1983. PT NOTED A RIGHT LATERAL BULGE 6 MONTHS AGO. NO HISTORY OF TRAUMA. THERE HAS BEEN A BILATERAL INCREASED PULLING SENSATION, AND PT NOTED A SMALL LUMP IN THE RIGHT UPPER BREAST ONE MONTH AGO, WITH NO CHANGES. PT DENIES DECREASE IN SIZE OR CHANGE IN TEXTURE. PT COMPLAINS OF SOME DEGREE OF FATIGUE, SLEEP DISTURBANCES, PARESTHESIAS, ADENOPATHY, HOT FLASHES/SWEATS, HEADACHES, MEMORY LOSS, AND EASY BRUISING. PT IS OTHERWISE HEALTHY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other| S