BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SQ MASTX

    MDR report key: 292104 · Received August 22, 2000

    Report

    Report Number
    MW1019722
    Event Type
    Injury
    Date Received
    August 22, 2000
    Date of Event
    February 18, 2000
    Report Date
    July 20, 2000
    Manufacturer
    SQ MASTX
    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 MULTIPLE FIBROADENOMAS. HAD PRIOR R BREAST BX AND FH + MAT GM WITH UNIL AFTER MENO BREAST CA. HAD B RECONSTRUCTION WITH MCGHAN GELS (? SIZE/TYPE-NO RECORDS). THESE WERE QUITE HARD INITIALLY BUT HAVE SOFTENED AND THE L HAS DEFINITELY CHANGED WITH EXTENSION INTO AXILLA AND LATERAL CHEST WALL SUCH THAT THE PT BELIEVES IT IS RUPTURED. SHE DENIES H/O TRAUMA. THE R HAS BEEN PAINFUL SECONDARY TO NEUROMA. SHE HAS SOME SYSTEMIC SX'S INCLUDING ARTHRALGIAS (+ AM STIFFNESS), HOT FLASHES, TMJD, SENS SUNLITE, CHOKING SENS, INCREASED CHOLESTEROL, WGT GAIN, AND GI/GU DISTURB. PT IS OTHERWISE HEALTHY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SQ MASTX GEL BREAST IMPLANTS FTR SQ MASTX NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other| S