BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COPPER C E

    MDR report key: 3934695 · Received July 10, 2014

    Report

    Report Number
    MW5037260
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 9, 2014
    Product Code
    HQZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    NOT SURE BUT I PURCHASED A NEW PAIR OF EYEGLASSES FROM (B)(6). NAME ON INSIDE SAYS "COPPER C E" SO EVIDENTLY HAS SOME ELEMENT OF COPPER IN THE PLASTIC. MY EARS HAVE BROKEN OUT WITH A BAD ITCHY, SCALY RASH THAT HURTS. I HAVE AN ALLERGY TO SOME METALS AND EVIDENTLY THE COPPER THEY USE IN THE PLASTIC AROUND THE EARS IS ONE OF THESE METALS. SHOULD THERE BE SOME TYPE OF WARNING WITH THIS TYPE OF EYEWEAR THAT ALERTS A CONSUMER THAT THIS MAY CAUSE A REACTION IN PEOPLE WITH AN ALLERGIC REACTION TO METALS? I AM TRYING TO CONTACT (B)(6) TO SEE IF I CAN GET A REPLACEMENT OR SOME REMEDY BECAUSE I PAID OVER (B)(6) AND NOW CANNOT WEAR THEM. WASN'T SURE HOW TO REPORT THIS PROBLEM OR TO WHOM. I SENT EMAIL TO (B)(6) AND TRIED TO FIND MANUFACTURER SITE OF THE EYEGLASSES BUT COULD NOT FIND AN ACTUAL SITE FOR COPPER C E. THANK YOU. FACILITY: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405537 COPPER C E NONE HQZ 52D16 135

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR