BEUDAMED
    FDA Adverse Event Other Summary report: N

    CICA-CARE

    MDR report key: 506893 · Received January 2, 2004

    Report

    Report Number
    MW1030725
    Event Type
    Other
    Date Received
    January 2, 2004
    Date of Event
    February 15, 2000
    Report Date
    January 2, 2004
    Manufacturer
    SMITH & NEPHEW
    Product Code
    FRO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SCAR-MANAGEMENT DRESSINGS SUCH AS CICA-CARE, REMATIX, REJUVENESS, SYPREX, XERAGEL OINTMENT, ENSIL, ETC. SHOULD BE REQUIRED TO LABEL THE SILICONE CONTENT. SILICONE NOSE PIECES ON EYEGLASSES SHOULD NEVER BE USED WITHOUT FIRST ASKING PTS IF THEY ARE ALLERGIC TO SILICONE. DEEP LESIONS WERE CARVED IN PT'S NOSE UNTIL PT WENT TO THE OPTOMETRIST FOR HELP WHO INSTANTLY SAID, "YOU HAVE SILICONE ALLERGY," AND REPLACED THE NOSE PIECES WITH VINYL. BECAUSE THE SILICONE CONTENT WAS UNLABELLED ON CICA-CARE, PT ATTEMPTED TO USE THIS FOR A BURN, WHICH SUPERIMPOSED SEVERE CONTACT DERMATITIS BY THE 3RD DAY OF USE ON THE BURNED SKIN. COMPANIES SHOULD BE REQUIRED TO LABEL ALL PRODUCTS WITH SILICONE THAT COME IN CONTACT WITH HUMAN SKIN. PRODUCTS WITH LATEX LABEL THE LATEX CONTENT, BUT THOSE WITH SILICONE USUALLY NO NOT LABEL THE SILICONE CONTENT. SILICONE ALLERGIES CANNOT POSSIBLY BE EXTREMELY RARE, SINCE AN OPTOMETRIST TECHNICIAN INSTANTLY DIAGNOSED MY PROBLEM, AS IF HE HAD REGULARLY EXPERIENCED SUCH COMPLAINTS. THE ABOVE DATE IS THE LATEST ADVERSE EFFECT PT SUFFERED FROM SILICONE WITH CICA-CARE FOR A BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CICA-CARE CUTANEOUS DRESSING FRO SMITH & NEPHEW * 9913STER/DOM9903

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other