BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HD400 PRESCRIPTION FRAME

    MDR report key: 5018911 · Received August 14, 2015

    Report

    Report Number
    MW5055602
    Event Type
    Injury
    Date Received
    August 14, 2015
    Date of Event
    August 13, 2015
    Report Date
    August 14, 2015
    Manufacturer
    VIVA INTERNATIONAL GROUP
    Product Code
    HQG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    WHILE DRIVING, THE HINGE ON MY (B)(6) PRESCRIPTION GLASSES FRAME FAILED, CAUSING THE GLASSES TO SLIDE OFF MY FACE. THIS RESULTED IN A SERIOUS HAZARD AS MY EYESIGHT WITHOUT CORRECTION IS NOT SUFFICIENT FOR DRIVING A VEHICLE. I WAS ABLE TO SAFELY STOP AND SWITCH TO MY PRESCRIPTION SUNGLASSES, BUT COULD EASILY HAVE BEEN INVOLVED IN AN ACCIDENT. THE HINGE OF THE RIGHT EARPIECE FAILED, CAUSING THE EARPIECE TO DETACH. THE HINGE HAS AN OVER-TRAVEL MECHANISM, AND THE PIVOT LINK APPEARS TO BE UNDER-DESIGNED. THERE IS VERY LITTLE MATERIAL AT CRUCIAL POINTS, ALLOWING METAL FATIGUE TO CAUSE FAILURE IN VERY FEW HINGE ACTUATION CYCLES. I HAVE THE GLASSES STILL, AND WOULD BE GLAD TO SEND THEM FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540129 HD400 PRESCRIPTION FRAME HD400 PRESCRIPTION FRAME HQG VIVA INTERNATIONAL GROUP HD400

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Life Threatening