BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIKE

    MDR report key: 10540323 · Received September 16, 2020

    Report

    Report Number
    10540323
    Event Type
    Malfunction
    Date Received
    September 16, 2020
    Date of Event
    June 30, 2020
    Report Date
    July 1, 2020
    Manufacturer
    BLOXR SOLUTIONS LLC
    Product Code
    KPY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    LEAD GLASSES LENS CRACKED DURING A CASE. NIKE LEAD GLASSES ORDERED FROM BLOXR (ONLY ABOUT 3 WEEKS OLD) AND THE LENS CRACKED WHILE WEARING THEM. THESE GLASSES WILL BE SENT BACK TO BLOXR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003847 NIKE SHIELD, PROTECTIVE, PERSONNEL KPY BLOXR SOLUTIONS LLC 7NKMEC6.0-NAV

    Patients

    Seq Age Sex Outcome Treatment
    1