BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 294631 · Received September 1, 2000

    Report

    Report Number
    MW1019837
    Event Type
    Malfunction
    Date Received
    September 1, 2000
    Date of Event
    August 30, 2000
    Report Date
    September 1, 2000
    Manufacturer
    UNK
    Product Code
    HOI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR PURCHASED CHEAP, CHINESE-MADE NON PRESCRIPTION READING GLASSES, WHITE METAL FRAMES, AND WORE THEM BRIEFLY 2 HRS. AWOKE THE FOLLOWING MORNING WITH VISCIOUS, LIVID WELTS UNDER EACH EYE WHERE THE EYEGLASS FRAME BRUSHED THE CHEEK. RPTR DID NOT ASSOCIATE THIS OCCURRENCE WITH THE EYEGLASSES INITIALLY. RPTR AGAIN WORE THE EYEGLASSES BRIEFLY AND WITHIN 90 MINS OR SO, REALIZED SKIN WAS BLISTERING. RPTR SUFFERS NO KNOWN ALLERGIES AND HAS NEVER EXPERIENCED A SIMILAR OCCURRENCE. THE ADVERSE REACTION WAS SO RAPID THAT RPTR OFFERS THIS INFO FOR FDA'S PERSUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK READING GLASSES HOI UNK UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other