BEUDAMED
    FDA Adverse Event Summary report: N

    SURGITEK GEL/SALINE INFLATABLE BREAST IMPLANT, 220/265 CC

    MDR report key: 13848 · Received June 7, 1994

    Report

    Report Number
    MW1002388
    Date Received
    June 7, 1994
    Report Date
    June 2, 1994
    Manufacturer
    MEDICAL ENGINEERING CORP.
    Product Code
    FTR
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR COMPLAINS OF: DIARRHEA, MELENA, PEPTIC DISEASE, COPD, CHEST PAIN, LOW BACK PAIN, SHORTNESS OF BREATH, BRONCHITIS, NAUSEA AND VOMITING, HIATAL HERNIA, GENERAL BODY MALAISE, CHILLS AND FEVER, ANOREXIA, ANXIETY DISORDER, SWELLING, PERIPHERAL VASCULAR DISEASE, GASTRITIS, DUODENITIS, EARLY OSTEOARTHRITIS, POSSIBLE IRRITABLE BOWEL, ULCERS, EMPHYSEMA, POSSIBLE IMPLANT RUPTURE, ARTHRITIS SYMPTOMS IN LEFT HAND AND ARM, SHOULDERS, ARMS, BACK AND FOOT SWELLING, LEGS GET RUN DOWN, FOOT AND FINGER JOINT SWELLING, PAIN AND STIFFNESS IN AM, VERY DRY SKIN, BREAST TENDERNESS AND PAIN WITH SHARP BURNING, FATIGUE, SWOLLEN GLANDS, GENERAL ACHING AND STIFFNESS, COLDNESS AND PAIN OF EXTREMITIES, WEIGHT LOSS, INCORRECT SIZE OF IMPLANTS, MALPOSITION OF LEFT IMPLANT, BREAST LOOKS CAVED IN, IMPLANT MIGRATES UNDERARM, MEMORY AND SLEEPING PROBLEMS, DEPRESSION, AND NUMBNESS AND TINGLING. SHE WAS HEALTHY BEFORE SHE HAD THE IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGITEK GEL/SALINE INFLATABLE BREAST IMPLANT, 220/265 CC FTR MEDICAL ENGINEERING CORP. 9483-79-K

    Patients

    Seq Age Sex Outcome Treatment
    1 *