BEUDAMED
    FDA Adverse Event Injury Summary report: N

    320:40

    MDR report key: 157810 · Received March 18, 1998

    Report

    Report Number
    MW1013232
    Event Type
    Injury
    Date Received
    March 18, 1998
    Report Date
    February 16, 1995
    Manufacturer
    CVI CORP.
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RT SALINE DEFLATION. PT IS 43-YR-OLD WHITE FEMALE, STATUS POST BILATERAL SUBGLANDULAR INFRAMAMMARY IMPLANTATION OF 320:40 CC CUI BILUMEN FOR AUGMENTATION ON 7/31/86. PT COMPLAINED OF BURNING PAIN IN RT WITH PARESTHESIAS FOR 2 YRS WITH NO HISTORY OF TRAUMA. PT ALSO COMPLAINED OF SYSTEMIC PROBLEMS OF ARTHRALGIAS, MYALGIAS, PARESTHESIAS, FATIGUE, FEVERS, SICCA, HAIR LOSS, RASHES, SOB, CHOKING SENSATION, GI/GU PROBLEMS, ETC. HISTORY OF MORBID OBESITY TREATED WITH STAPLING IN 83, OTHERWISE HEALTHY, EX-SMOKER, FAMILY HISTORY OF 3 PATERNAL AUNTS HAVING BREAST CANCER POSTMENOPAUSALLY. MAMMOGRAM ON 11/10/93 WITHIN NORMAL LIMITS. EXAM SHOWS GRADE III CONTRACTURE IN RT, GRADE I CONTRACTURE IN LT, AXILLARY LYMPH NODES WITH DRY SKIN AND STOMATITIS. SURGERY ON 11/11/93 SHOWS BOTH IMPLANTS DEFLATED, SEAL LOOSE, MODERATE CLOUDYNESS, MINIMUM YELLOWING WITH MODERATE BLEED ON RT CAPSULE, MODERATE CONTRACTION WITH NO HISTIOCYTES, WEIGHT OF RT 330, LT 350.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 320:40 Implant 320:40 SILICON GEL (BILUMEN) FTR CVI CORP. SGR-320:40 K30609

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other| S