BEUDAMED
    FDA Adverse Event Summary report: N

    MAXENON XI300

    MDR report key: 1048748 · Received May 6, 2008

    Report

    Report Number
    1048748
    Date Received
    May 6, 2008
    Date of Event
    March 27, 2008
    Report Date
    May 5, 2008
    Manufacturer
    QED
    Product Code
    GCT
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    1.5 HOURS INTO PROCEDURE, NOTICED PATIENT'S LEFT EAR WAS SWOLLEN AND SKIN WAS BLISTERED AND WARM. THE EPIDERMIS STARTED TO SLOUGH OFF. WE COVERED THE EAR WITH A SALINE SOAKED GAUZE. SILVER SULFADIAZINE APPLIED AT THE END OF CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXENON XI300 LIGHT SOURCE, XENON GCT QED MID3010 *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR