BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 2549221 · Received April 16, 2012

    Report

    Report Number
    2311923-2012-00010
    Event Type
    Injury
    Date Received
    April 16, 2012
    Date of Event
    March 12, 2006
    Report Date
    April 16, 2012
    Manufacturer
    JK PRODUCTS & SERVICES, INC.
    Product Code
    LEJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER DID NOT USE THE REQUIRED EYE PROTECTION EYE PROTECTION AS CLEARLY LABELED ON THE DEVICE.

    Description of Event or Problem · 1

    CLAIMANT ALLEGEDLY INCURRED EYE INJURY USING TANNING DEVICE. CLAIMANT WAS NOT WEARING EYE PROTECTION WHILE TANNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE LEJ JK PRODUCTS & SERVICES, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other