BEUDAMED
    FDA Adverse Event Summary report: N

    DOUBLE LUMEN MAMMARY IMPLANT, 220/260 CC

    MDR report key: 17156 · Received October 25, 1994

    Report

    Report Number
    MW1003802
    Date Received
    October 25, 1994
    Report Date
    October 19, 1994
    Manufacturer
    MCGHAN MEDICAL CORP.
    Product Code
    FTR
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    FLU SYMPTOMS, MIGRAINE HEADACHES, SKIN RASHES, BREAST TENDERNESS, FATIGUE, SWOLLEN GLANDS, COLDNESS AND PAIN OF EXTREMITIES, INCORRECT SIZE OF IMPLANTS, NIPPLES LOOKED HORRIBLE, LEFT BREAST HAS SLOSHING NOISES, SEVERE PAIN DURING IMPLANTATION, NAUSEA, VOMITTING, RIBCAGE PAIN, BREAST SUTURES OPENED, DEHISCENCE OF LEFT BREAST WOUND EXPOSED LEFT BREAST IMPLANT, BROKEN CAPILLARIES OF RIGHT THIGH. (ALSO SEE 1003801.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOUBLE LUMEN MAMMARY IMPLANT, 220/260 CC Implant BREAST IMPLANT FTR MCGHAN MEDICAL CORP. STYLE 76 EA3149

    Patients

    Seq Age Sex Outcome Treatment
    1 *