BEUDAMED
    FDA Adverse Event Summary report: N

    LOW BLEED MODERATE PROFILE ROUND GEL BREAST IMPLANT, 225 CC

    MDR report key: 12411 · Received March 30, 1994

    Report

    Report Number
    MW1001333
    Date Received
    March 30, 1994
    Report Date
    March 24, 1994
    Manufacturer
    MENTOR CORP.
    Product Code
    FTR
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT EXPERIENCED THE FOLLOWING SYMPTOMS: PREGNANCY AFTER IMPLANTS, SPIDER VEINS IN LEGS, SHOULDER PROBLEMS, DEPRESSION, CAPSULAR CONTRACTURES, NECK AND ARM PAIN, ARTHRITIS SYMPTOMS, MUSCLE FATIGUE, SWELLING OF HANDS AND FINGERS, FATIGUE, LEFT SIDE AND SHOULDER NUMBNESS, SWOLLEN NECK GLANDS, WEIGHT LOSS, COLD HANDS AND FEET, AND ONE IMPLANT IS HIGHER THAN THE OTHER. (ALSO SEE 1001334.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOW BLEED MODERATE PROFILE ROUND GEL BREAST IMPLANT, 225 CC FTR MENTOR CORP. STYLE 7000 10367

    Patients

    Seq Age Sex Outcome Treatment
    1 *