BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 157808 · Received March 18, 1998

    Report

    Report Number
    MW1013231
    Event Type
    Injury
    Date Received
    March 18, 1998
    Date of Event
    March 24, 1995
    Report Date
    June 16, 1997
    Manufacturer
    CVI CORP.
    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

    PT IS A 31-YR-OLD FEMALE, G1P1, STATUS POST IMPLANTATION OF SUBGLANDULAR 280 CC GELS IN 6/7/85. HISTORY PERTINENT FOR APPENDICECTOMY IN 1972 AND LAPAROSCOPY 3 TIMES DURING THE PERIOD OF 1988 TO 1991 FOR ENDOMETRIOSIS. TEN YEARS FOLLOWING PLACEMENT, LT IMPLANT RUPTURED WHEN IV STAND FELL ON CHEST, RT RUPTURED IN A CAR ACCIDENT. LOCAL AND SYSTEMIC COMPLAINTS ARE: BILATERAL CAPSULES REMOVED ON 3/24/95, ARTHRITIS, FIBROMYALGIA, MUSCLE SPASMS, NUMBNESS, SWELLING, HARD LUMPS, CHRONIC FATIGUE, LOW GRADE FEVER, REGULAR INFECTIONS, HOT FLASHES, PAIN IN GUMS AND TEETH, VISION PROBLEMS, DIZZINESS, MEMORY LOSS, DEPRESSION, DRY MUCUS MEMBRANES, HAIR LOSS, SORES, ULCERS IN MOUTH, SKIN LESIONS OR BLISTERS, SENSTIVITY TO COLD, SUN AND CHEMICALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * Implant GEL BREAST IMPLANTS FTR CVI CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other| S