BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRALITE PRO MODULE

    MDR report key: 3326931 · Received August 29, 2013

    Report

    Report Number
    1222895-2013-00019
    Event Type
    Injury
    Date Received
    August 29, 2013
    Date of Event
    August 21, 2013
    Report Date
    August 29, 2013
    Manufacturer
    INTEGRA BURLINGTON, MA, INC.
    Product Code
    FCW
    PMA / PMN Number
    K864380
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    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

    MIRROR INSIDE MODULE IS SHATTERED (HAS HIT THE FLOOR ON OCCASION). DR (B)(6) USED IT IN A PROCEDURE AND THE LIGHT BURNED THROUGH THE PLASTIC AND BURNED HIS NOSE. UNKNOWN IF ANY TREATMENT NEEDED. INCIDENT HAPPENED ON (B)(6) 2013. ON (B)(6) 2013, CUSTOMER REPORTS THE DOCTOR DID NOT NEED TREATMENT. CUSTOMER HAS NO IDEA HOW LONG THE DEVICE WAS IN USE BEFORE EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427132 ULTRALITE PRO MODULE NA FCW INTEGRA BURLINGTON, MA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1