BEUDAMED
    FDA Adverse Event Summary report: N

    SALINE 1600 ROUND BREAST IMPLANT, 525 CC

    MDR report key: 17423 · Received November 3, 1994

    Report

    Report Number
    MW1003903
    Date Received
    November 3, 1994
    Report Date
    October 31, 1994
    Manufacturer
    MENTOR CORP.
    Product Code
    FWM
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HEEL PAIN, RHINITIS, HIGH BLOOD PRESSURE, UNABLE TO VOID, CEBACEOUS CYST ON BACK, HEADACHE, ACHINESS, TINGLING/NUMBNESS RT ARM AND SHOULDER WEAKNESS, BRUISES EASILY, TIREDNESS, JOINT PAIN, FIBROSITIS, TROUBLE SLEEPING, ABSCESSES, ASTHMA, RESPIRATORY PROBLEMS, KIDNEY PROBLEMS, BREAST HARDNESS, SENSITIVITY AND NUMBNESS, NIPPLES HAVE BREAK-OUTS, GENERAL ACHING AND STIFFNESS, MALPOSITION OF IMPLANTS, LOSS OF UPPERBODY STRENGTH, TENDONITIS, MYALGIC DISCOMFORT IN ARMS AND LEGS, FEVERS, CHILLS, PARESTHESIAS, SICCA SYMPTOMS. (ALSO SEE 1003902)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SALINE 1600 ROUND BREAST IMPLANT, 525 CC BREAST IMPLANT FWM MENTOR CORP. 91051, 91810

    Patients

    Seq Age Sex Outcome Treatment
    1 *