BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESCRIPTION GLASSES

    MDR report key: 7244554 · Received February 5, 2018

    Report

    Report Number
    MW5075076
    Event Type
    Injury
    Date Received
    February 5, 2018
    Report Date
    February 3, 2018
    Manufacturer
    MARCHON
    Product Code
    HQG
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD AN ALLERGIC REACTION TO MY NEW GLASSES THAT WERE PRESCRIBED BY MY OPTOMETRIST, DR. (B)(6) IN (B)(6). WITHIN A DAY OF WEARING THE GLASSES, I DEVELOPED A PAINFUL AND ITCHY RASH EVERYWHERE THE FRAMES TOUCHED MY SKIN. THE FRAMES WERE CALVIN KLEIN 5975 CL. CALVIN KLEIN 5975.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86629 PRESCRIPTION GLASSES PRRECRIPTION GLASSES HQG MARCHON 5975 CL

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Disability