BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPLIGHT

    MDR report key: 769673 · Received October 13, 2006

    Report

    Report Number
    2914019-2006-00084
    Event Type
    Injury
    Date Received
    October 13, 2006
    Date of Event
    April 1, 2006
    Report Date
    October 13, 2006
    Manufacturer
    LUMENIS
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS HAS HAD THE SUBJECT EPILIGHT SYSTEM IN ITS POSSESSION SINCE 2006. INCIDENT AND SERVICE DETAILS HAVE BEEN REQUESTED FROM LUMENIS. A FOLLOW-UP REPORT WILL BE FILED IF ADDTIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    REPORTER INFORMED LUMENIS REGULATORY IN 2006, THAT A PATIENT TREATED WITH THE EPILIGHT AT A LOCATION SIX MONTHS EARLIER IS ALLEGING BURNS AND SCARRING TO THE LOWER BACK. PER LUMENIS UK, DURING THE TREATMENT, THE HEADS LEAKED WATER AND GOT HOT. ADDITIONAL DETAILS HAVE BEEN REQUESTED BY LUMENIS REGULATORY AND ARE PENDING AS OF SIX MONTHS FOLLOWING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPLIGHT INTENSE PULSE LIGHT DELIVERY DEVICE GEX LUMENIS GA4100002 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other REQUESTED AND PENDING AS OF 10/13/2006