BEUDAMED
    FDA Adverse Event Summary report: N

    DOUBLE LUMEN MAMMARY IMPLANT, 220/260 CC

    MDR report key: 14045 · Received June 15, 1994

    Report

    Report Number
    MW1002492
    Date Received
    June 15, 1994
    Manufacturer
    MCGHAN MEDICAL CORP.
    Product Code
    FTR
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR HAD THIS CO'S IMPLANTS IMPLANTED ON 3/18/91, TO REPLACE PREVIOUS IMPLANTS. SHE HAS HAD SOME HARDENING OF HER BREAST, IMTERMITTENT SWELLING, DISCOMFORT, STINGING AND BURNING SENSATIONS IN HER RIGHT ARM. (*) (SAME RPTR REFERRED TO IN 1002490 AND 1002491.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOUBLE LUMEN MAMMARY IMPLANT, 220/260 CC Implant FTR MCGHAN MEDICAL CORP. STYLE 178

    Patients

    Seq Age Sex Outcome Treatment
    1 *