BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EYEGLASSES NON POLYCARBONATE

    MDR report key: 19269477 · Received May 7, 2024

    Report

    Report Number
    MW5154657
    Event Type
    Injury
    Date Received
    May 7, 2024
    Date of Event
    February 15, 2024
    Report Date
    May 3, 2024
    Manufacturer
    UNKNOWN
    Product Code
    HOI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    CONSUMER LOST SIGHT IN ONE EYE AFTER HER VEHICLE AIRBAG DEPLOYED AND SHATTERED HER NON POLYCARBONATE GLASSES. SEE RELEVANT ARTICLE: HTTPS://WWW.11ALIVE.COM/ARTICLE/MONEY/CONSUMER/SUNGLASSES-SAFETY-IN-CRASH/85-7A8EEBDC-3478-42E5-A9E5-465DAC28425B. CONSIDER NOTIFYING ALL RELEVANT OPTICAL PROFESSIONALS AND REQUIRING TAGS ON ALL NON-POLYCARBONATE GLASSES WARNING OF SAFETY HAZARD SHOULD NOT BE USED WHILE DRIVING. MOTOR VEHICLE OWNER¿S MANUALS SHOULD SPECIFY THIS RISK AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1357930 EYEGLASSES NON POLYCARBONATE SPECTACLE, MAGNIFYING HOI UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization