BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XENON LIGHT SOURCE 300 WATT W/

    MDR report key: 7066629 · Received November 29, 2017

    Report

    Report Number
    2523190-2017-00135
    Event Type
    Injury
    Date Received
    November 29, 2017
    Date of Event
    October 18, 2017
    Report Date
    November 6, 2017
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    KOG
    PMA / PMN Number
    K992006
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2017 INTEGRA INVESTIGATION COMPLETED. METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION. RESULTS: FAILURE ANALYSIS FAILURE ANALYSIS CANNOT BE COMPLETED DUE TO THE LACK OF INFORMATION RECEIVED TO PERFORM A COMPLETE INVESTIGATION. PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION. UNCONFIRMED/NO RETURN OF DEVICE FOR EVALUATION. DEVICE HISTORY RECORD REVIEWED, NO ABNORMALITIES RELATED TO THE REPORTED FAILURE. ROOT CAUSE CANNOT BE DETERMINED DUE TO THE LACK OF INFORMATION RECEIVED TO PERFORM A COMPLETE INVESTIGATION. PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTS PATIENT WAS INJURED : PATIENT'S EYES/CORNEAS BECOME BLURRY, SUPERFICIAL BURN THAT WILL HEAL WITHOUT ANY TRACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846532 XENON LIGHT SOURCE 300 WATT W/ N/A KOG INTEGRA YORK, PA INC. 071207

    Patients

    Seq Age Sex Outcome Treatment
    1 Other