BEUDAMED
    FDA Adverse Event Other Summary report: N

    SALINE IMPLANTS

    MDR report key: 2222997 · Received August 21, 2011

    Report

    Report Number
    MW5021833
    Event Type
    Other
    Date Received
    August 21, 2011
    Date of Event
    July 8, 2008
    Report Date
    August 21, 2011
    Product Code
    FWM
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAVING SALINE IMPLANTS FOR OVER 3 YEARS, I HAVE HAD SEVERE RASHES AND GOING TO SEVERAL SPECIALISTS AND MY (B)(6) -IMMUNE SYSTEM IS OVER 1400. BEEN ON "PREDICONE" ALL THAT TIME AND STILL HAVE SEVERE BLOW-UPS. HAD ALL BLOOD TESTS AVAILABLE EVEN THE NEW ONE TO TEST BONE MARROW AND ALL WERE NEGATIVE. WAS TOLD THE IMPLANTS TEST WAS NEGATIVE, BUT COULD THIS BE THE RESULTS? I AM WILLING TO HAVE THEM OUT, BUT WANT TO KNOW IF SALINE IMPLANTS CAN CAUSE THIS ALLERGIC REACTION. THANK YOU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SALINE IMPLANTS SALINE IMPLANTS FWM

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other