BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 334614 · Received May 23, 2001

    Report

    Report Number
    MW1021973
    Event Type
    Injury
    Date Received
    May 23, 2001
    Date of Event
    November 3, 2000
    Report Date
    May 15, 2001
    Manufacturer
    NA
    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 LEFT SUBGLA INFRA GEL FOR HYPOPLASIA BILATERAL DONUT PEK CORRECTION OF TUBULAR BREAST DEFORMITY 1984. PT COMPLAINED OF PAIN IN LEFT SINCE SYMPTOMS BUT THIS HAS INCREASED IN RECENT YEARS. THE PT HAS SHOOTING PAIN AND NOW CONSTANT LATERAL BURNING PAIN/ITCH. IN RECENT YEARS THE BREAST FEELS HOT TO THE PT. IT SEEMS MORE ROUND RECENTLY WITHOUT DECREASED SIZE. PT HAS HISTORY OF TRAUMA TO THE BREAST 2 YRS AGO. PT ALSO COMPLAINED OF SYSTEMIC PROGRESSIVE DX'S SINCE THE PT'S TEENS. THE PT IS NOT SURE WHEN THEY DEVELOPED IN RELATION TO IMPLANT, THESE INCLUDES ARTHRAIGUAS/PARETHESIAS, SWELLING, FATIGUE, SLEEP DISTURBANCES, FREQUENT URIS, HOT FEELING HEADACHES, DIZZINESS, MEMORY PROBLEMS, SENSITIVE TO SUN, TEARING IN LEFT EYE, SENSITIVE TO ODORS, WGT GAIN, EASY BRUISING, GI/GU C/O'S PLUS CHANGE IN VAG ODOR FACIAL ACNE, HAIR GROWTH, PT OTHERWISE HEALTHY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24044 NA GEL BREAST IMPLANTS FTR NA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other| S