BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTICA EYEGLASS FRAMES

    MDR report key: 2554585 · Received April 26, 2012

    Report

    Report Number
    MW5025202
    Event Type
    Malfunction
    Date Received
    April 26, 2012
    Date of Event
    October 1, 2011
    Report Date
    April 19, 2012
    Manufacturer
    ADVANTICA
    Product Code
    HQZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PLASTIC NOSE BRIDGE ON PRESCRIPTION GLASSES IS GROWING FUNGUS/ALGAE AND EXHIBITING GREENISH CORROSION. POSSIBLE RISK TO EYESIGHT. BRIDGE REPLACED AT 3 MONTHS, NEW ONE IS EQUALLY DEFECTIVE. VENDOR REPLACED ORIGINAL PART AFTER 4 MONTHS ((B)(6)), REPLACEMENT PART IS JUST AS BAD AS ORIGINAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANTICA EYEGLASS FRAMES EYEGLASS FRAMES HQZ ADVANTICA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR