BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM TEXTURE MAMMARY OVAL SINGLE LUMEN

    MDR report key: 3161531 · Received June 7, 2013

    Report

    Report Number
    MW5030462
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    August 8, 1990
    Report Date
    June 7, 2013
    Manufacturer
    MEGHAN MEDICAL CORP
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER CALLED TO REPORT ABOUT THE NUMEROUS ISSUES SHE HAS BEEN HAVING SINCE SHE HAD SILICONE BREAST IMPLANTED IN 1990. SHE REPORTS THAT HER BREAST ARE NOW VERY SWOLLEN. SHE HAS SWOLLEN LYMPH NODES IN HER GROIN, THROAT AND ARMPITS. HER CONNECTIVE TISSUES HURT AND SHE SUFFERS FROM EDEMA ALL OVER HER BODY ESPECIALLY ON HER LEGS AND HANDS. SHE ALSO SAID WHEN THE IMPLANTED RUPTURED, SILICONE LEAKED OUT TO DIFFERENT PARTS OF HER BODY INCLUDING HER LUNGS, SPLEEN AND KIDNEYS CAUSING GRANULOMAS AND LYMPHOMAS. SHE ALSO SUFFERS FROM REOCCURRING INFECTIONS WHICH ARE NOT RESPONSIVE TO ANTIBIOTICS. DUE TO FUNGI INFECTIONS HER FINGER NAILS HAVE FALLEN OFF LEAVING WOUNDS AND SCARS THAT WILL NOT HEAL; NOW THEY LOOK RED, SWOLLEN AND NASTY. SHE SUFFERS FROM EXCESSIVE THIRST WHICH LEFT BER DEHYDRATED AND CAUSED KIDNEY STONES. FURTHER MORE; SHE HAS NEUROLOGICAL DEFICIENCIES WHICH MAKE TALKING AND THINKING DIFFICULT. THERE IS ALSO SOME KIND OF SKIN GROWTH ON HER KNEE AND SHE HAS JOINT PAIN ALL OVER HER BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252556 CUSTOM TEXTURE MAMMARY OVAL SINGLE LUMEN SILICONE BREAST IMPLANT FTR MEGHAN MEDICAL CORP D29374-R
    252557 CUSTOM TEXTUR MAMMARY OVAL SINGLE LUMEN SILICONE BREAST IMPLANT FTR MEGHAN MEDICAL CORP DY4620-L

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR