BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXENON XI 300-WATT XENON LIGHT SOURCE

    MDR report key: 3581602 · Received January 16, 2014

    Report

    Report Number
    3005775121-2014-00001
    Event Type
    Injury
    Date Received
    January 16, 2014
    Date of Event
    July 23, 2013
    Report Date
    January 2, 2014
    Manufacturer
    QED, INC
    Product Code
    FST
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) WAS THE DISTRIBUTOR OF THIS PRODUCT AT THE TIME OF THE OCCURRENCE. (B)(4) NO LONGER SELLS THIS PRODUCT. THE MANUFACTURER IS QED, INC. (B)(4) WAS NOT MADE AWARE OF THE OCCURRENCE BY THE FACILITY BUT BY THE MANUFACTURER OF THE LARYNGOSCOPE, (B)(6). (B)(4) HAS NOT REC'D THE LIGHT SOURCE TO CONDUCT AN INVESTIGATION. (B)(4) HAS NO RECORDS OF THE LIGHT SOURCE SENT IN FOR REPAIR AT ANY TIME NOR IS THERE A RECORD OF THE FACILITY PURCHASING REPLACEMENT LAMPS FROM (B)(4).

    Description of Event or Problem · 1

    (B)(4) REC'D NOTIFICATION ON 12/09/2013 THAT A PATIENT REC'D A BURN ON HIS LIP FROM A MEDTRONIC LARYNGOSCOPE DURING LARYNGEAL SURGERY. IT WAS REPORTED THAT THE LARYNGOSCOPE WAS CONNECTED TO A (B)(4) MAXENON XI 300-WATT XENON LIGHT SOURCE. (B)(4) HAS NOT BEEN CONTACTED BY THE FACILITY NOR WAS IT INFORMED OF AN ISSUE AT THE TIME OF THE OCCURRENCE AND HAS NOT REC'D THE LIGHT SOURCE FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41781 MAXENON XI 300-WATT XENON LIGHT SOURCE MAXENON XI 30-WATT XENON LIGHT SOURCE FST QED, INC BFW 3010 NI

    Patients

    Seq Age Sex Outcome Treatment
    1