BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTLEWAVES

    MDR report key: 2853153 · Received August 5, 2008

    Report

    Report Number
    3004591004-2008-00001
    Event Type
    Injury
    Date Received
    August 5, 2008
    Date of Event
    July 25, 2008
    Report Date
    July 25, 2008
    Manufacturer
    LIGHT BIOSCIENCE LLC
    Product Code
    GEX
    PMA / PMN Number
    K031425
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    SUBJECT WAS ENROLLED (RANDOMIZED) IN A (B)(4) STUDY ON (B)(6) 2008. ON (B)(6) 2008, SUBJECT WAS ADMITTED TO THE HOSPITAL FOR STOMACH PAIN. THE SUBJECT UNDERWENT DIAGNOSTIC TESTING AND WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2008. ON (B)(6) 2008, THE SUBJECT UNDERWENT INITIAL TREATMENT PER STUDY PROTOCOL. ON (B)(6) 2008, A DIAGNOSIS OF STOMACH CANCER WAS CONFIRMED AND COMMUNICATED TO THE INVESTIGATOR. (B)(6) IS THE STUDY SPONSOR USING A US COMMERCIALLY AVAILABLE NON-SIGNIFICANT RISK DEVICE. THE STUDY IS BEING CONDUCTED AT: (B)(6). BASED ON INITIAL EVALUATION, THE EVENT APPEARS TO BE UNRELATED TO USE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENTLEWAVES LED PHOTOMODULATION DEVICE GEX GEX LIGHT BIOSCIENCE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| O PROPOXYPHENE 100 MG