BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCGHAN

    MDR report key: 289275 · Received July 27, 2000

    Report

    Report Number
    MW1019532
    Event Type
    Injury
    Date Received
    July 27, 2000
    Date of Event
    September 22, 1994
    Report Date
    July 5, 2000
    Manufacturer
    MCGHAN
    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 (ONE L BX, FH NEGATIVE BREAST CA) WITH IMMEDIATE SUBMUSC IMPLANT RECONSTRUCTION. PT HAD POLIO WITH SEVERE KYPHOSCOLIOSIS AND ASYM OF BREASTS. HAD 205CC MCGHAN GELS ON R AND 190CC GELS ON L (? TYPE, NO RECORDS). DUE TO CONTINUED ASYM, UNDERWENT EXCHANGE WITH B 255CC GELS. THE L WAS FOUND TO BE RUPTURED. C/O CONT'D ASYM SINCE THAT SX WITH DEVELOPMENT OF DISCOMFORT FOR SEVERAL YEARS, L MORE THAN R. THE R SEEMS TO BE GETTING SMALLER, NO H/O TRAUMA AND IS RUPTURED ON MRI. ALSO HAS SYSTEMIC C/O'S INCLUDING ARTHRALGIAS (+ AM STIFFNESS), MYALGIAS, DYSESTHESIAS/PARESTHESIAS, FATIGUE, SLEEP DISTURB, HOT FLASHES, SWEATS, HEADACHES, DENTAL PROBS, VISUAL DISTURB, DIZZY SPELLS, MEMORY PROBS, DRY MUCUS MEMBRANES, RASHES, SENS SUN/COLD, SOB/CP, COSTOCHONDRITIS, HTN, WGT GAIN, GI DISTURB, AND EASY BRUISING. PT IS OTHERWISE HEALTHY."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other| S