BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE GEL BREAST IMPLANTS

    MDR report key: 289618 · Received July 26, 2000

    Report

    Report Number
    MW1019563
    Event Type
    Injury
    Date Received
    July 26, 2000
    Report Date
    December 22, 1998
    Manufacturer
    SQ
    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

    "S/P B SQ MASTX'S FOR FCD. HAD B SQ SMALL CRONIN GELS FOR RECONSTRUCTION. THESE ENCAPSULATED SHORTLY AFTERWARDS, L MORE PAINFUL THAN R. IN 1995 HAD R THORACOTOMY FOR EXC BX BENIGN LESION AND SINCE THE SX, C/O INCREASING R BREAST PAIN - THIS IS SHARP AND PARALYZING WHEN PT BENDS FORWARD. THE ENCAPSULATION CONTINUED TO WORSEN. C/O SX INCLUDING MYALGIAS, (+ AM STIFFNESS), PARESTHESIAS/DYSESTHESIAS, SPASMS, FATIGUE, SWELLING, SLEEP DISTURBANCES, ADENOPATHY, VISUAL CHANGES, WORD LOSS, DEPRESSION, SICCA, SEN CHEM, COSTOCHONDRITIS, CHOKING SENS, HTN, WGT GAIN, EASY BRUISING, AND GU DISTURBANCES. PT IS OTHERWISE HEALTHY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE GEL BREAST IMPLANTS SMALL CRONIN GELS FTR SQ UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other| S