BEUDAMED
    FDA Adverse Event Other Summary report: N

    NONE

    MDR report key: 4270823 · Received November 18, 2014

    Report

    Report Number
    MW5039198
    Event Type
    Other
    Date Received
    November 18, 2014
    Report Date
    September 29, 2014
    Product Code
    HQZ
    Report Source
    Voluntary report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I AM FILING A CONCERN, NOT A COMPLAINT. I BELIEVE (B)(4) SOLD THE EYEGLASS FRAMES I PURCHASED FROM THEM IN GOOD FAITH AND DID NOT KNOW THESE FRAMES COULD HAVE A DETRIMENTAL EFFECT ON THE WEARER. AT A RECENT VISION EXAM, I WAS TOLD THE REASON I WAS HAVING DIFFICULTY WITH POWER VISION WAS HAT THE FRAMES I WAS USING HAD BEEN MADE IN (B)(4) WHERE LOW GRADE METALS ARE OFTEN USED IN PRODUCTS. I ALSO BECAME AWARE THAT CONTINUAL USE OF THESE FRAMES WAS RESULTING IN AN ALLERGIC REACTION, CAUSING CONGESTION AND PAIN ALONG THE SIDE OF MY NOSE AND CIRCLING UP UNDER MY EYEBROW. NOW THAT I AM WEARING A HYPOALLERGENIC FRAME, NOT MADE IN (B)(4), MY VISION HAS IMPROVED AS WELL AS A DRAMATIC IMPROVEMENT IN MY NASAL PASSAGES. LOSS: NOT FILING FOR REIMBURSEMENT. RELIEF REQUESTED: I WOULD APPRECIATE YOUR INFORMING (B)(4) THAT THEY ARE SELLING EYEGLASS FRAMES MADE IN (B)(4) THAT HAVE CAUSED AT LEAST ONE CUSTOMER TO HAVE DIFFICULTY WITH VISION AS WELL AS AN ALLERGIC REACTION. I DO NOT WANT TO RETURN THESE FRAMES FOR A REFUND BUT WANT TO SEND THEM TO SOME AGENCY WHICH CAN PERFORM A CHEMICAL ANALYSIS THAT CAN DETERMINE WHAT TOXINS ARE PRESENT AND PROVIDE DOCUMENTATION, SO THAT THESE FRAMES CANNOT BE SOLD IN THE UNITED STATES. PLEASE LET ME KNOW WHERE I CAN SEND THESE FRAMES. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744212 NONE EYEGLASS FRAME HQZ

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR